A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT ID: NCT07043218

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2027-06-30

Brief Summary

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.

Detailed Description

This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T cells（ chimeric antigen receptor T cells）

CT1190B-P and CT1192 cells infusion

Group Type: EXPERIMENTAL

Chimeric Antigen Receptor T Cells (CAR-T)

Intervention Type: DRUG

chimeric antigen receptor T cells

Interventions

Chimeric Antigen Receptor T Cells (CAR-T)

chimeric antigen receptor T cells

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements

2. 18-75 years old;

3. Histologically or cytologically confirmed B-ALL;

4. Previously received at least 2 lines of systemic therapy;

5. Expected survival > 12 weeks;

6. Eastern Cooperative Oncology Group (ECOG) score 0-2;

7. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.

Exclusion Criteria

1. Pregnant or lactating women;

2. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);

3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);

4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;

5. Patients with isolated extramedullary lesions;

6. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;

7. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;

8. Patients with heart disease in the 6 months prior to screening;

9. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;

10. Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Aibin Liang，MD，Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aibin Liang MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Aibin Liang MD,Ph.D.

Role: CONTACT

lab7182@tongji.edu.cn

+86 21 6611 1019

Ping Li MD

Role: CONTACT

lilyforever@126.com

+86 135 6418 1131

Facility Contacts

Aibin Liang MD，Ph.D.

Role: primary

lab7182@tongji.edu.cn

+86 21 6611 1019

Ping Li MD

Role: backup

lilyforever@126.com

+86 135 6418 1131

Other Identifiers

CT119X-CG11004

Identifier Type: -

Identifier Source: org_study_id