A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute… (NCT07043218) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
China36 participantsStarted 2025-07-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. 18-75 years old;
✓. Histologically or cytologically confirmed B-ALL;
✓. Previously received at least 2 lines of systemic therapy;
✓. Expected survival \> 12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) score 0-2;
✓. 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
✕. Pregnant or lactating women;
✕. 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);
✕. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
✕. 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;
What they're measuring
1
MTD and/or dose range
Timeframe: Up to 28 days after CAR-T cells infusion
2
Adverse Events (AE) after CT119X infusion
Timeframe: 12 months after CT119X infusion
Trial details
NCT IDNCT07043218
SponsorShanghai Tongji Hospital, Tongji University School of Medicine
✕. Patients with isolated extramedullary lesions;
✕. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
✕. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
✕. Patients with heart disease in the 6 months prior to screening;