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Drug

Loncastuximab tesirine

Approved · EMA
Late-stage development

Also known as Zynlonta, Humanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through A protease cleavable valine-alanine linker.

RxNorm2540964UNII7K5O7P6QIU
14
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Clinical trial2026-07-17Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Clinical trial2026-07-10Results expected Q1 2027 · ClinicalTrials.gov

A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Clinical trial2026-06-30Results expected Q4 2026 · ClinicalTrials.gov

Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma

Clinical trial2026-06-05Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2 Study of Loncastuximab Tesirine and Rituximab as Bridging Therapy Prior to Standard-of-care CD19 CAR T-cell Therapy in Patients With Large B-cell Lymphoma

Clinical trial2026-05-29Results expected Q1 2027 · ClinicalTrials.gov

A Pilot Study of Loncastuximab Tesirine in Specific Populations of Relapsed/Refractory B-Cell Malignancies

Clinical trial2026-05-21Terminated · ClinicalTrials.gov

A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy

Clinical trial2026-05-20Results expected Q1 2030 · ClinicalTrials.gov

A Phase 1/2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)

Clinical trial2026-05-07Results expected Q2 2030 · ClinicalTrials.gov

A Phase II Study Evaluating Loncastuximab Tesirine in Patients With Previously Treated Waldenström Macroglobulinemia

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

Clinical trial2026-03-31Primary completion · ClinicalTrials.gov

Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

Clinical trial2026-03-23Results expected Q3 2027 · ClinicalTrials.gov

Approval: Zynlonta (EMA)

Regulatory2022-12-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Loncastuximab tesirine
Aliases & brands
ZynlontaHumanized monoclonal immunoglobulin G1 antibody directed against human CD19 conjugated to SG3199 through A protease cleavable valine-alanine linker
RxNorm CUI
2540964
UNII
7K5O7P6QIU
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-12-20
Latest approval
2022-12-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-12-20Approval
Approval: Zynlonta (EMA)
Indication: Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL),… Show full indication

Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
22
registered trials across all phases
LATEST COMPLETION 2022
14
Active studies
10
Recruiting
2
Late-stage (III+)
1
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 22
Phase 15Phase 1 / 22Phase 213Phase 2 / 31Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

RecruitingPH II/IIIUniversity of Birminghamn=2102033

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

Active, not recruitingPH IIIADC Therapeutics S.A.n=4402028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-2)

CompletedPH IIADC Therapeutics S.A.n=1452022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.