Skip to main content
Clinical Trials/NCT04689659
NCT04689659
Completed
Phase 2

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

Beijing Boren Hospital1 site in 1 country55 target enrollmentDecember 1, 2021

Overview

Phase
Phase 2
Intervention
chimeric antigen receptor T cell treatment
Conditions
T-cell Leukemia/Lymphoma
Sponsor
Beijing Boren Hospital
Enrollment
55
Locations
1
Primary Endpoint
Efficacy: Best overall response (BOR) rate
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
April 3, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

chimeric antigen receptor T cell treatment

Intervention: chimeric antigen receptor T cell treatment

Outcomes

Primary Outcomes

Efficacy: Best overall response (BOR) rate

Time Frame: at 3 months

Best overall response (BOR) rate to the CAR T treatment

Study Sites (1)

Loading locations...

Similar Trials