CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies

Phase 2

Completed

• Conditions: Hematological Malignancies
• Interventions: Drug: Anti-CD7 CAR-T

• Registration Number: NCT05454241
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Study Start: 2022-09-07
• Status Verified: 2023-06
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Diagnosed CD7 positive relapsed/refractory hematological malignancies.
2. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
4. The estimated survival time is more than 3 months;
5. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria

1. Patients with history of epilepsy or other central nervous system diseases;
2. Patients with prolonged QT or severe heart disease;
3. Pregnant or lactating women
4. Patients with uncontrolled active infection.
5. Positive for any of the following etiological tests: HIV, HBV, HCV
6. Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-CD7 UCAR-T cells	Anti-CD7 CAR-T	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate(ORR)	1 Year	Number of patients who achieved response after treatment of CD7 CAR-T cell.

Secondary Outcome Measures

Name	Time	Method
Duration of overall response (DOR)	1 Year	Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Overall survival(OS)	1 Year	OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China