Epcoritamab-CAR T Cells for Large B-cell Lymphomas

NCT06458439 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: UPCC 03424IRB#855865
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.

Conditions

Lymphoma, Non-Hodgkin; Relapsed Diffuse Large B Cell Lymphoma; Refractory Diffuse Large B-cell Lymphoma; High-grade B-cell Lymphoma; Transformed Indolent Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of CAR T cell infusion among subjects who receive epcoritamab and undergo leukapheresis

  Whether participants receive CAR T-cell infusion (yes/no)

  Start of epcoritamab to CAR T-cell infusion

Secondary Outcomes (8)

• Incidence and severity of AEs, SAEs from epcoritamab until CAR T cell infusion

  Day 1 of epcoritamab until CAR T cell infusion

• Overall Response Rate after 2 cycles of Epcoritamab

  Day 1 of epcoritamab to completion of 2 cycles of epcoritamab

• Incidence and severity of AEs, SAEs after CAR T cell infusion through day 28 visit after CAR T-cell infusion

  CAR T cell infusion through day 28 visit after CAR T-cells

• Day 28 visit response rates post CAR T cell infusion

  Day 28 visit after CAR T cell infusion

• Progression-free survival, duration of response, and overall survival for those subjects achieving complete response at Day 28 visit post CAR T cell infusion

  CAR T cell infusion until last follow-up or death

Study Arms (1)

Epcoritamab

EXPERIMENTAL

Study participants will bridging epcoritamab on Cycles 1-3, Days 1, 8, 15, and 22 (once weekly).

Drug: Epcoritamab

Interventions

Epcoritamab DRUG

* C1D1: fixed priming dose of 0.16 mg subcutaneous injection * C1D8: fixed intermediate dose of 0.8 mg subcutaneous injection * C1D15 onward: fixed full dose of 48 mg subcutaneous injection

Also known as: GEN3013, DuoBody -CD3xCD20

Epcoritamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.
• Able to comply with the study protocol, in the investigator's judgment
• ECOG PS of 0 - 2
• Pathology report confirming eligible diagnosis
• Documented CD20+ tumor cells on most recent biopsy
• Patients will have failed to respond to frontline standard of care therapy containing an anthracycline and anti-CD20 antibody
• Patients will be eligible and consent to be treated with a "commercially available" anti-CD19, 4-1BB, CD3zeta CAR-T cell therapy or anti-CD19, CD28, CD3zeta CAR T cell therapy (for example, tisagenlecleucel, lisocabtagene maraleucel, or axicabtagene maraleucel)
• Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver)
• Adequate laboratory studies
• Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
• Ability and willingness to take proper contraceptive precautions

You may not qualify if:

• Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.
• Prior solid organ transplantation
• Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.
• Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
• Patients with a history of lymphoma-related immune thrombocytopenic purpura or autoimmune hemolytic anemia in remission may be eligible for this study if approved by the Regulatory Sponsor and Principal Investigator
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• i. Rash must cover \< 10% of body surface area ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroid iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or corticosteroids (\> 20 mg/day prednisone or equivalent for \> 2 weeks) within the previous 3 months d. rheumatoid arthritis or similar autoimmune/rheumatic conditions
• Systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). However, the following are permitted:
• If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control.
• Patients who received a single dose of a systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) may be enrolled
• The use of inhaled corticosteroids is permitted
• The use of mineralocorticoids for management of orthostatic hypotension is permitted
• The use of physiologic doses of corticosteroids (\< 20 mg/day of prednisone or equivalent) for uses such as management of adrenal insufficiency is permitted
• Cervical carcinoma of Stage 1B or less.
• Adequately resected, non-metastatic basal cell or squamous cell skin carcinoma.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Genmab: collaborator

Study Sites (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Elise Chong, MD

  Abramson Cancer Center at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Koch

CONTACT

215-776-5548; Brittany.Koch@pennmedicine.upenn.edu

Kaitlin Kennard

CONTACT

Kaitlin.Kennard@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)