Actively Recruiting
Phase IIa Trial to Evaluate Epcoritamab Administered Before and After CAR-T Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphomas
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-27
31
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of epcoritamab treatment before and after CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphomas. The study aims to see if epcoritamab can be given safely before CAR T-cell infusion and if it can help treat any remaining lymphoma after CAR T-cell therapy. This is a phase 2a clinical trial sponsored by the Abramson Cancer Center at Penn Medicine. Participants will receive epcoritamab as a bridging therapy during the first three cycles on days 1, 8, 15, and 22. The dosing starts with a low priming dose of 0.16 mg subcutaneously on day 1, an intermediate dose of 0.8 mg on day 8, and full doses of 48 mg from day 15 onward. After CAR T-cell infusion, some participants may continue to receive epcoritamab for up to 12 cycles to address residual lymphoma. During the study, participants will be monitored from the start of epcoritamab through CAR T-cell infusion and follow-up, including assessments of side effects and response to treatment. Researchers will measure outcomes such as successful CAR T-cell infusion after epcoritamab treatment, response rates after two cycles of epcoritamab, safety through adverse event tracking, and survival outcomes up to five years. Imaging scans, laboratory tests, and clinical evaluations will be used to track lymphoma status and treatment effects throughout the study period.
CONDITIONS
Brief Title
Epcoritamab-CAR T Cells for Large B-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Able and willing to provide informed consent or have a legally authorized representative provide consent
- Able to comply with the study protocol as judged by the investigator
- ECOG performance status of 0 to 2
- Pathology report confirming eligible diagnosis of large B-cell lymphoma
- Documented CD20 positive tumor cells on most recent biopsy
- Failure to respond to frontline standard therapy containing an anthracycline and anti-CD20 antibody
- Eligible and consent to treatment with a commercially available anti-CD19 CAR T-cell therapy
- Have a PET/CT, diagnostic CT, or MRI scan with at least one measurable lesion
- Adequate laboratory studies
- Resolution of prior therapy toxicities to a grade that allows participation
- Ability and willingness to use proper contraceptive precautions
You will not qualify if you...
- Inability or unwillingness to provide informed consent
- Prior solid organ transplantation
- Primary central nervous system lymphoma or active CNS involvement by lymphoma
- History of autoimmune disease causing permanent immunosuppression or requiring chronic immunosuppressive therapy, with some exceptions
- Use of systemic immunosuppressive medications beyond allowed doses
- Past or current malignancies other than the lymphoma being studied, except certain treated cancers in remission
- Known significant cardiovascular disease
- Active infections including hepatitis B, hepatitis C, or HIV
- Active bacterial, viral, fungal, mycobacterial, parasitic, or other major infections at enrollment
- Clinically significant pulmonary disease requiring chronic oxygen or high-dose corticosteroids
- Uncontrolled seizure disorder
- Exposure to live vaccine within 4 weeks before consent
- Pregnancy or breastfeeding
- Any serious medical condition or lab abnormality that precludes safe participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of Epcoritamab
Participants receive weekly subcutaneous injections of Epcoritamab on Cycles 1-3, Days 1, 8, 15, and 22 before and after CAR T-cell therapy.
Weekly visits for up to 12 weeks during initial cycles and additional visits for post-CAR T-cell infusion dosing
Duration - Up to 5 years
Participants are monitored after CAR T-cell infusion for response, safety, and survival outcomes up to 5 years from the last dose of Epcoritamab.
Visits at Day 28 post CAR T-cell infusion and at 3 and 6 months, with longer-term follow-up visits
Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
B
Brittany Koch
K
Kaitlin Kennard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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