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

Hematological Malignancies Clinical Trial

Official title:

Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454241
• Other study ID #: RD13-02
• Status: Recruiting
• Phase: Phase 2
• Start date: September 7, 2022
• Est. completion date: September 7, 2025

Study information

• Verified date: June 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Ying Wang, doctor
• Phone: +86-22-23909278
• Email: wangying1[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 7, 2025
• Est. primary completion date: September 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Intervention

Drug:
• Anti-CD7 CAR-T
Universal CAR-T cells targeting CD7

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Ying Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate(ORR)	Number of patients who achieved response after treatment of CD7 CAR-T cell.	1 Year
Secondary	Duration of overall response (DOR)	Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.	1 Year
Secondary	Overall survival(OS)	OS will be assessed from the CAR-T cell infusion to death or last follow-up.	1 Year