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

NCT05454241 | Completed Phase 2

• 1 other identifier: IIT2022020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancies

Keywords

T-ALL/LBL; AML

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate(ORR)

  Number of patients who achieved response after treatment of CD7 CAR-T cell.

  1 Year

Secondary Outcomes (2)

• Duration of overall response (DOR)

  1 Year

• Overall survival(OS)

  1 Year

Study Arms (1)

anti-CD7 UCAR-T cells

EXPERIMENTAL

Drug: Anti-CD7 CAR-T

Interventions

Anti-CD7 CAR-T DRUG

Universal CAR-T cells targeting CD7

anti-CD7 UCAR-T cells

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ying Wang, Dr.

  Hematology Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 12, 2022
• Study Start: September 7, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)