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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Tongji Hospital, Tongji University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Chimeric Antigen Receptor T Cells (CAR-T)

Treatment groups

36 Participants
are divided into 1 treatment group