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RecruitingLast updated: 22 June 2026

EpLCART: This study is evaluating Epcoritamab immunotherapy by itself, or in combination with other medicines, as consolidation treatment following anti-CD19 CAR T-cell therapy for people with large B-cell lymphomaA Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

EpLCART

Clinical summary

Summary

People who have received CAR T-cell therapy for relapsed or refractory large B-cell lymphoma, are in Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) and MRD positive post CAR T-cell infusion are potentially eligible to participate in this trial.

Eligible participants will be randomly allocated (by chance) to one of two arms: Arm A wil receive Epcoritamab alone, and Arm B will receive Epcoritamab plus Lenalidomide and Rituximab. 

Participants will undergo an interim response assessment after 2 cycles of treatment. Participants that complete the full 6 cycles of treatment or that discontinue treatment for any reason will have an End of Treatment visit and a Safety Follow-up visit at 60 days after Day 1 of Cycle 6.

Participants with non-Progressive Disease then enter the follow-up phase of the study where they will undergo response assessments at month 12, 15, 18 and 24 after CAR T-cell infusion.

Participants that have completed the month 24 follow-up visit or that have progressed will be followed for survival and new anti-lymphoma therapy only.

All participants will be followed for 2 years after the last participant randomised received the CAR T-cell infusion.

Conditions

This trial is treating people with relapsed or refractory large B-cell lymphoma

Eligibility

Inclusion

  1. Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  3. A diagnosis of relapsed/refractory large B-cell lymphoma
  4. Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.
  5. Partial metabolic response (PMR) or complete metabolic response (CMR) as per the Lugano criteria on the most recent PET/CT performed at any point between Day +25 and Day +100 post CAR T-cell infusion, when compared with the most recent PET/CT prior to CAR T-cell infusion.
  6. MRD positive by a ctDNA assay on a blood sample taken at any point between Day +25 and Day +100 post CAR T-cell infusion.
  7. Adequate haematological function documented within 7 days prior to randomisation
  8. Adequate cardiac function.
  9. Adequate renal function, documented within 7 days prior to randomisation
  10. Adequate hepatic function documented within 7 days prior to randomisation
  11. Complete resolution of cytokine release syndrome (CRS), macrophage-activation syndrome (MAS)/haemophagocytic lymphohistiocytosis (HLH) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to prior CAR T-cell therapy.
  12. Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method/procedure as outline in the PICF
  13. Sexually active males must agree to use a condom during sexual contact with a pregnant female or a FCBP for the course of the study through to 4 months after the last dose of epcoritamab, even if he has undergone a successful vasectomy
  14. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of epcoritamab
  15. The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol

Exclusion

  1. A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy
  2. Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy
  3. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment
  4. Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20
  5. A diagnosis of primary central nervous system (CNS) lymphoma
  6. Active secondary CNS involvement of lymphoma at time of screening
  7. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression
  8. Known cognitive impairment would place the patient at increased risk of complications from ICANS
  9. A known history of hepatitis B serology consistent with acute or chronic infection
  10. A known history of hepatitis C serology consistent with acute or chronic infection
  11. A known history of testing positive for human immunodeficiency virus (HIV)
  12. Any comorbidity conferring a life expectancy of < 5 years (e.g., second malignancy) or that in the opinion of the site investigator may significantly impact the ability to complete the trial therapy and follow-up or affect the interpretation of results
  13. Exposed to live or live attenuated vaccine within 4 weeks prior to signing the PICF.
  14. Women who are pregnant or lactating
  15. Known hypersensitivity to epcoritamab, lenalidomide, rituximab, tocilizumab or their excipients
  16. Presence of any psychological, social or geographical or other condition for which participation would not be in the best interest of the patient

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre, Australia

Scientific Title

A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma

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