Relapsed/Refractory Large B-cell LymphomaPhase 2EpLCARTNCT06414148
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
A Phase 2 study testing Epcoritamab and Epcoritamab, lenalidomide and rituximab in people with Relapsed/Refractory Large B-cell Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 6 sites in Australia.
Trial summary
This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Relapsed/Refractory Large B-cell Lymphoma
- What is being tested?
- Epcoritamab and Epcoritamab, lenalidomide and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesAustralia
- Study dates
- 14 May 2024to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- A diagnosis of relapsed/refractory large B-cell lymphoma
- Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.
- 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.
- 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.
Show all 15Show fewer
- Adequate haematological function documented within 7 days prior to randomisation
- Adequate cardiac function.
- Adequate renal function, documented within 7 days prior to randomisation
- Adequate hepatic function documented within 7 days prior to randomisation
- 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.
- Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method/procedure as outline in the PICF
- 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
- 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
- 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
Who cannot join
- A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy
- Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy
- Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment
- Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20
- A diagnosis of primary central nervous system (CNS) lymphoma
- Active secondary CNS involvement of lymphoma at time of screening
Show all 16Show fewer
- A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression
- Known cognitive impairment would place the patient at increased risk of complications from ICANS
- A known history of hepatitis B serology consistent with acute or chronic infection
- A known history of hepatitis C serology consistent with acute or chronic infection
- A known history of testing positive for human immunodeficiency virus (HIV)
- 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
- Exposed to live or live attenuated vaccine within 4 weeks prior to signing the PICF.
- Women who are pregnant or lactating
- Known hypersensitivity to epcoritamab, lenalidomide, rituximab, tocilizumab or their excipients
- Presence of any psychological, social or geographical or other condition for which participation would not be in the best interest of the patient
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Not yet recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Not yet recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3000
Shafqat Inam, +61390766000, S.Inam@alfred.org.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Michael Dickinson, +61385995000, michael.dickinson@petermac.org
- Not yet recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Emily Blyth, +61288905555, emily.blyth@sydney.edu.au
About this study
Official 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 (EpLCART)
This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.
Read the detailed description
Patients who have received CAR T-cell therapy for Relapsed/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. Once these patients have provided their consent, they will enter the screening phase. All events of Cytokine Release Syndrome (CRS), Haemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS), Immune-Effector Cell Associated Neurologic Syndrome (ICANS), or infection must have completely resolved. Additionally, patients must have adequate organ and haematological function, and an ECOG performance status of up to 2.
Patients deemed eligible for the study will be randomised to receive Epcor-only (Arm A) or Epcor-R2 (Arm B) for 6 cycles. The primary endpoint is CMR by Lugano 2014 criteria at month 12 post CAR T-cell infusion.
Patients will undergo an interim response assessment after 2 cycles of treatment. Patients 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. Patients with non-Progressive Disease (PD) 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. Patients with PD at any time will complete a Progression visit. Patients that have completed the month 24 Follow-up visit or that they have progressed will be followed for survival and new anti-lymphoma therapy only. All patients will be followed for 2 years after the last patient randomised received the CAR T-cell infusion.
- Being tested
- Epcoritamab, Epcoritamab, lenalidomide and rituximab
- Keywords
- Minimal Residual Disease, Large B-Cell Lymphoma, Anti-CD19, CAR T, ctDNA, Lymphoma, DLBCL, HGBL, Epcoritamab, Lenalidomide, Rituximab
- Medical subject headings
- Recurrence, Neoplasm, Residual, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Epcoritamab will be administered as a 28-day cycle. In Cycle 1 and 2, epcoritamab will be given with step up dosing in Cycle 1. From Cycle 3 onwards dosing will be on Day 1 and 15 of each cycle.
Epcoritamab, lenalidomide and rituximabDrug
Treatment with epcoritamab will be administered following the same dosing schedule as Arm A. On days where rituximab and/or lenalidomide are also due, epcoritamab should be administered last.
Patients will receive lenalidomide once daily on Day 1-21 of each 28-day cycle, starting at Cycle 1 through to Cycle 6.
Patients will receive rituximab administered by intravenous (IV) infusion on Day 1, 8, 15 and 22 of Cycle 1 and on Day 1 only of Cycles 2-6.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | EPCORITAMAB (EPCOR-ONLY) Receives: Drug: Epcoritamab |
| Arm B | Experimental | EPCORITAMAB, LENALIDOMIDE AND RITUXIMAB (EPCOR-R2) Receives: Drug: Epcoritamab, lenalidomide and rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Epcor-only (epcoritamab alone) or Epcor-R2 (epcoritamab, lenalidomide and rituximab) consolidation as assessed by conventional (Lugano 2014) response criteria at month 12 after the CART infusion
Measured: From start of treatment till the end of study, assessed up to approximately 12 months
Secondary outcomes (5)
To evaluate the safety of time-limited Epcor-only or Epcor-R2 consolidation post CAR T-cell therapy according to number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
Measured: From start of treatment till the end of study, assessed up to approximately 48 months
The efficacy as assessed by molecular and conventional response criteria at defined time points with Event Free Survival (EFS) analyses
Measured: From start of treatment till the end of study, assessed up to approximately 48 months
The efficacy as assessed by molecular and conventional response criteria at defined time points with Overall Survival (OS) analyses
Measured: From start of treatment till the end of study, assessed up to approximately 48 months
The deliverability as assessed by rates of completion of the course of therapy
Measured: From start of treatment till the end of study, assessed up to approximately 6 months
The deliverability as assessed by protocol-defined number of dose-reductions of lenalidomide
Measured: From start of treatment till the end of study, assessed up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 May 2024
- Primary completionOct 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase II open-label, two-arm randomised non-comparative, multicentre study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Michael Dickinson, MBBS, D Med Sc, FRACP, FRCPA, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414148
- Sponsor's protocol ID
- 22/012
- Acronym
- EpLCART
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 (EpLCART)
- ClinicalTrials.gov ID
- NCT06414148
- Acronym / sponsor ID
- EpLCART / 22/012
- Keywords
- Minimal Residual Disease, Large B-Cell Lymphoma, Anti-CD19, CAR T, ctDNA, Lymphoma, DLBCL, HGBL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 14 May 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.
Detailed description
Patients who have received CAR T-cell therapy for Relapsed/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. Once these patients have provided their consent, they will enter the screening phase. All events of Cytokine Release Syndrome (CRS), Haemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS), Immune-Effector Cell Associated Neurologic Syndrome (ICANS), or infection must have completely resolved. Additionally, patients must have adequate organ and haematological function, and an ECOG performance status of up to 2.
Patients deemed eligible for the study will be randomised to receive Epcor-only (Arm A) or Epcor-R2 (Arm B) for 6 cycles. The primary endpoint is CMR by Lugano 2014 criteria at month 12 post CAR T-cell infusion.
Patients will undergo an interim response assessment after 2 cycles of treatment. Patients 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. Patients with non-Progressive Disease (PD) 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. Patients with PD at any time will complete a Progression visit. Patients that have completed the month 24 Follow-up visit or that they have progressed will be followed for survival and new anti-lymphoma therapy only. All patients will be followed for 2 years after the last patient randomised received the CAR T-cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A phase II open-label, two-arm randomised non-comparative, multicentre study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: EpcoritamabEPCORITAMAB (EPCOR-ONLY) |
| Arm B | Experimental | Drug: Epcoritamab, lenalidomide and rituximabEPCORITAMAB, LENALIDOMIDE AND RITUXIMAB (EPCOR-R2) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- A diagnosis of relapsed/refractory large B-cell lymphoma
- Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.
- 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.
Key exclusion criteria (16 listed)
- A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy
- Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy
- Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment
- Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20
- A diagnosis of primary central nervous system (CNS) lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabEpcoritamab will be administered as a 28-day cycle. In Cycle 1 and 2, epcoritamab will be given with step up dosing in Cycle 1. From Cycle 3 onwards dosing will be on Day 1 and 15 of each cycle. | Drug | Arm A |
| Epcoritamab, lenalidomide and rituximabTreatment with epcoritamab will be administered following the same dosing schedule as Arm A. On days where rituximab and/or lenalidomide are also due, epcoritamab should be administered last. Patients will receive lenalidomide once daily on Day 1-21 of each 28-day cycle, starting at Cycle 1 through to Cycle 6. Patients will receive rituximab administered by intravenous (IV) infusion on Day 1, 8, 15 and 22 of Cycle 1 and on Day 1 only of Cycles 2-6. | Drug | Arm B |
Primary outcome
The efficacy of Epcor-only (epcoritamab alone) or Epcor-R2 (epcoritamab, lenalidomide and rituximab) consolidation as assessed by conventional (Lugano 2014) response criteria at month 12 after the CART infusion
Time frame: From start of treatment till the end of study, assessed up to approximately 12 months
5 secondary outcomes
To evaluate the safety of time-limited Epcor-only or Epcor-R2 consolidation post CAR T-cell therapy according to number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
Time frame: From start of treatment till the end of study, assessed up to approximately 48 months
The efficacy as assessed by molecular and conventional response criteria at defined time points with Event Free Survival (EFS) analyses
Time frame: From start of treatment till the end of study, assessed up to approximately 48 months
The efficacy as assessed by molecular and conventional response criteria at defined time points with Overall Survival (OS) analyses
Time frame: From start of treatment till the end of study, assessed up to approximately 48 months
The deliverability as assessed by rates of completion of the course of therapy
Time frame: From start of treatment till the end of study, assessed up to approximately 6 months
The deliverability as assessed by protocol-defined number of dose-reductions of lenalidomide
Time frame: From start of treatment till the end of study, assessed up to approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Large B-cell Lymphoma
RecruitingPhase 1
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL)
Active, not recruitingPhase 3
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Relapsed or Refractory Large B-cell Lymphoma
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
Active, not recruitingPhase 1
Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Dickinson, MBBS, D Med Sc, FRACP, FRCPA principal investigator
Peter MacCallum Cancer Centre, Australia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epcoritamab and Epcoritamab, lenalidomide and rituximab in people with Relapsed/Refractory Large B-cell Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of Epcor-only (epcoritamab alone) or Epcor-R2 (epcoritamab, lenalidomide and rituximab) consolidation as assessed by conventional (Lugano 2014) response criteria at month 12 after the CART infusion (time frame: From start of treatment till the end of study, assessed up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.