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

• Sponsor: Ying Wang (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05454241
• Collaborator: (none)
• Enrollment: 22
• Arm: 1
• Anticipated Duration (Months): 13.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies	Drug: Anti-CD7 CAR-T	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
• Anticipated Study Start Date: Aug 25, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anti-CD7 UCAR-T cells	Drug: Anti-CD7 CAR-T; Universal CAR-T cells targeting CD7

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate(ORR) [1 Year]

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

Secondary Outcome Measures

1. 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.

2. Overall survival(OS) [1 Year]

   OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ying Wang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ying Wang, Professor, Institute of Hematology & Blood Diseases Hospital
• ClinicalTrials.gov Identifier: NCT05454241
• Other Study ID Numbers: RD13-02
• First Posted: Jul 12, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ying Wang, Professor, Institute of Hematology & Blood Diseases Hospital: T-ALL/LBL; AML
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Jul 12, 2022