Shanghai Tongji Hospital, Tongji University School of Medicine
Phase
Phase 1
Started
2025-07-10
Last updated
2025-06-29
Condition(s) studied
B-cell Acute Lymphoblastic Leukemia
Investigational drug(s) / intervention(s)
Chimeric Antigen Receptor T Cells (CAR-T)
Chimeric Antigen Receptor T Cells (CAR-T): chimeric antigen receptor T cells
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Shanghai Tongji Hospital
Shanghai
Shanghai Municipality
More Shanghai Tongji Hospital, Tongji University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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