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

Not Applicable

Not yet recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Drug: Chimeric Antigen Receptor T Cells (CAR-T)

• Registration Number: NCT07043218
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-22
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-10
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T cells（ chimeric antigen receptor T cells）	Chimeric Antigen Receptor T Cells (CAR-T)	CT1190B-P and CT1192 cells infusion

Primary Outcome Measures

Name	Time	Method
MTD and/or dose range	Up to 28 days after CAR-T cells infusion	Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion
Adverse Events (AE) after CT119X infusion	12 months after CT119X infusion	An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	12 months after CT119X infusion	The time from the infusion of CT119X cells to the first assessment of disease progression or death.
Overall response rate （ORR）	Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion	The proportion of patients with complete remission（CR）/partial response (PR) after CT119X infusion.
Complete response rate (CRR)	12 months after CT119X infusion	The proportion of patients with complete response(CR) after CT119X infusion
Duration of remission(DOR)	12 months after CT119X infusion	Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.
Time to response (TTR)	12 months after CT119X infusion	The time from cell infusion to the first assessment of CR or PR
Time to complete response (TTCR)	12 months after CT119X infusion	The time from cell infusion to the first assessment of CR
Overall survival (OS)	12 months after CT119X infusion	defined as the time from the date of receiving the infusion to the date of death from any cause

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China