Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma

Phase 2

Completed

• Conditions: Refractory T Lymphoblastic Leukemia/Lymphoma; Relapse/Recurrence; T-cell Leukemia/Lymphoma
• Interventions: Biological: chimeric antigen receptor T cell treatment

• Registration Number: NCT04689659
• Lead Sponsor: Beijing Boren Hospital

Brief Summary

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Study Start: 2021-12-01
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chimeric antigen receptor T cell treatment	chimeric antigen receptor T cell treatment	-

Primary Outcome Measures

Name	Time	Method
Efficacy: Best overall response (BOR) rate	at 3 months	Best overall response (BOR) rate to the CAR T treatment

Trial Locations

Locations (1)

Beijing Boren Hospital; 🇨🇳 Beijing, Beijing, China