Loncastuximab Tesirine-Lpyl

Biologic
Given by a clinician
Identity checked
Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

Loncastuximab tesirine-lpyl is an antibody-drug conjugate (ADC) targeting CD19. The monoclonal IgG1 kappa antibody component binds to human CD19, a transmembrane protein expressed on the surface of cells of B-lineage origin. The small molecule component is SG3199, a PBD dimer and alkylating agent. Upon binding to CD19, loncastuximab tesirine-lpyl is internalized followed by release of SG3199 via proteolytic cleavage.

Why people take it. ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts: Not recorded.
Kind of result: No result is published, so no kind of result applies yet
Supervision: Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 154 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Unacceptable toxicity (Safety Lead-in)

The study did not show it

Who was studied: NCT05672251
How many people: 36
Study design: Phase 2
Compared against: Not recorded for this study
Kind of result: A number that stands in for health
What was found: Result not recorded on this page
Repeated elsewhere: Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

openFDA Drugs@FDA · a recorded source, not a stored snapshot
FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Complete response rate

The study did not show it

Who was studied: NCT05600686
How many people: 24
Study design: Phase 2
Compared against: Not recorded for this study
Kind of result: A number that stands in for health
What was found: Result not recorded on this page
Repeated elsewhere: Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

openFDA Drugs@FDA · a recorded source, not a stored snapshot
FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Overall response rate (ORR)

The study did not show it

Who was studied: NCT05453396
How many people: 11
Study design: Phase 2
Compared against: Not recorded for this study
Kind of result: A number that stands in for health
What was found: Result not recorded on this page
Repeated elsewhere: Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

openFDA Drugs@FDA · a recorded source, not a stored snapshot
FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

The maximum tolerated dose (MTD).

The study did not show it

Who was studied: NCT05270057
How many people: 11
Study design: Phase 1
Compared against: Not recorded for this study
Kind of result: A number that stands in for health
What was found: Result not recorded on this page
Repeated elsewhere: Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

openFDA Drugs@FDA · a recorded source, not a stored snapshot
FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

What we know: RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it: Each card names the study, the number of people and what the study set out to measure.
What this does not prove: These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters: A study that failed is as informative as one that worked, and both are here.
What we still do not know: No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell

Who is missing from the studies

Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

On pediatric, the label states: “Safety and effectiveness of ZYNLONTA in pediatric patients have not been established.”
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30
On older people, the label states: “Of the 145 patients with large B-cell lymphoma who received ZYNLONTA in clinical trials, 55% were 65 years of age and older, while 14% were 75 years of age and older [see Clinical Studies (14.1) ] .”
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, ZYNLONTA can cause embryo-fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (SG3199) and affects actively dividing cells [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1) ] .”
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no data on the presence of loncastuximab tesirine-lpyl or SG3199 in human milk, the effects on the breastfed child, or milk production.”
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN or total bilirubin > 1 to 1.5 × ULN and any AST).”
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30

Where the result stopped carrying

This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)

It was studied for a different goal: The studies measured something else entirely. Nothing in this record points to this reason.
There was nothing to correct: Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too: In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel: A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it: Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet: The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied: Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time: Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says: Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason: RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4, S7.

No source is stored against this line.

What is in the pack

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

ZYNLONTA is intravenous at 3 DOSAGE FORMS AND STRENGTHS For Injection: 10 mg of loncastuximab tesirine-lpyl as a white to off-white lyophilized powder in a single-dose vial for reconstitution and further dilution., recorded as fda label in effect 2026-06-12 in the United States.
US prescribing information · af54af12-3edf-4301-8bc5-0446bc813c1d · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

Biosimilar of
Loncastuximab tesirine
Evidence on this page does not automatically apply to this one.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

Which of the trials of Loncastuximab Tesirine-Lpyl studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Loncastuximab Tesirine-Lpyl are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleNothing found in the sources checked

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Nothing found in the sources checked

No traced study record is stored for this substance.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Checks this page had to pass

Passed
Identity resolved
no open identity hold
Passed
No unresolved merge across substance families
no quarantine open
Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4, S7.
Passed
Canonical metadata present
slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

1 approved application covers products containing this substance. The earliest was BLA761196, approved 20210423 to ADC Therapeutics SA.
Drugs@FDA application register · BLA761196 · read 2026-08-29
Marketing status on the register: prescription.
Drugs@FDA application register · BLA761196 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

Which studies of this failed, and what did they measure?Surface a meaningful outcome
Were people like me actually studied?Reveal a population mismatch
How close is this evidence to something I would notice?Reveal the evidence boundary
What does nobody know about this yet?Reveal an important unknown
What is a formulation?Support deeper learning

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (6)

On the Loncastuximab Tesirine-Lpyl label: indicated for what?

"ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is…": indications and usage on Loncastuximab Tesirine-Lpyl's label. DailyMed label · af54af12-3edf-4301-8bc5-0446bc813c1d · 2026-08-30

23 registered trials of Loncastuximab Tesirine-Lpyl — at which phases?

Registered studies posting no result: 16 of 23

23 registered studies of Loncastuximab Tesirine-Lpyl: 12 phase2, 10 phase1, 2 phase3, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1 with a PubMed record

Show the evidence

phase2
12
phase1
10
phase3
2
na or unstated
1
terminated
7
recruiting
6

4 more recorded rows

active not recruiting
5
completed
2
withdrawn
2
no longer available
1

recorded 2026-09-01 · last checked 2026-09-04

9 of Loncastuximab Tesirine-Lpyl's trials stopped: safety, accrual/recruitment, sponsor decision unspecified, other?

safety (2), accrual/recruitment (3), sponsor decision unspecified (1) and other (3): Loncastuximab Tesirine-Lpyl's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was early terminated prior to part 2 because of slow accrual."; 9 of 23 registered studies

Show the evidence

Trial

NCT02669264
terminated; "The study was early terminated prior to part 2 because of slow accrual."
NCT03684694
terminated; "Administrative decision"
NCT03685344
terminated; "In a limited number of patients, no additional activity was evident for the combination vs. loncastuximab tesirine monotherapy."
NCT04699461
terminated; "Administrative decision (not due to safety reason)"
NCT04974996
withdrawn; "Decision to not proceed with study."
NCT05144009
terminated; "The benefit-risk profile does not support continuation of the LOTIS-9 trial."

3 further recorded trials

NCT05228249
withdrawn; "PI left institution and funding sponsor closed study. Study did not open to accrual, and no participants were enrolled."
NCT05453396
terminated; "The trial closed early due to slow accrual."
NCT05660395
terminated; "This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision."

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Loncastuximab Tesirine-Lpyl could settle lifespan?

NCT04384484 measures Progression-free Survival (PFS), reading out 2028-06-30.

1 open trial; n 440; "Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma"

Show the evidence

Trial NCT04384484
"Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma"; n 440; "Progression-free Survival (PFS)"; 2028-06-30

At the median, Loncastuximab Tesirine-Lpyl's trials enrolled 27.5 people — anything larger?

Median enrolment: 27.5
Largest enrolment: 440
Registered trials counted: 22