JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07024147
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • B-Cell Non-Hodgkin Lymphoma
  • Follicular Lymphoma
  • Large B Cell Diffuse Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JWCAR239 — BIOLOGICAL
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells targeting CD19/CD20
  • Fludarabine — DRUG
    Administered according to package insert
  • Cyclophosphamide — DRUG
    Administered according to package insert

Study Details

JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)

Key Dates

First listed
Jun 17, 2025
Start date
Jul 1, 2025
Status verified
May 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JWCAR239 arm
    Participants will receive cyclophosphamide 250-300mg/m\^2/day intravenously (IV) and fludarabine 25-30mg/m\^2/day IV conditioning chemotherapy for 3 days followed by JWCAR239 administered as a single IV infusion at a target dose of 2 .5-30x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day 1.

Primary Outcome Measure

The rate of Dose Limiting Toxicity events [ Time Frame: 28 days ]

Central Contacts

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