CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

Phase 1

Recruiting

• Conditions: T-Cell Non-Hodgkin Lymphoma; T-cell Lymphoma (PTCL and CTCL)
• Interventions: Drug: CD7 CAR-T cells infusion

• Registration Number: NCT06925464
• Lead Sponsor: Beijing GoBroad Hospital

Brief 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 CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 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 CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Study First Posted: 2025-04-13
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD7 CAR-T therapy	CD7 CAR-T cells infusion	Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	21 days	Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion.
Adverse events (AEs)	21 days	Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	21, 90 days	The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion.
Duration of response (DOR)	up to 2 years	DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse

Trial Locations

Locations (4)

湛江中心人民医院; 🇨🇳 湛江市, 广东, China

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Liquan Hospital; 🇨🇳 Shanghai, Shanghai, China