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CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

NCT07022964 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-06-15

No results posted yet for this study

Summary

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Conditions

  • T-Cell Non-Hodgkin Lymphoma
  • T-cell Lymphoma (PTCL and CTCL)

Interventions

DRUG

CD5 CAR-T cells infusion

Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai Liquan Hospital

    collaborator OTHER

  • Beijing GoBroad Hospital

    lead OTHER

Principal Investigators

  • Tengyu Wang, Ph.D · Beijing GoBroad Hospital, Beijing, Beijing 102200

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-06-01
Completion
2028-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022964 on ClinicalTrials.gov