A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chimeric Antigen Receptor T Cells (CAR-T).
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of Universal CAR-T Cell in Patients With CD19 and/or CD20 Positive Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.
Overview
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.
Interventions
- Drug Chimeric Antigen Receptor T Cells (CAR-T)
chimeric antigen receptor T cells
Primary outcome measures
- MTD and/or dose range [Time frame: Up to 28 days after CAR-T cells infusion]
- Adverse Events (AE) after CT119X infusion [Time frame: 12 months after CT119X infusion]
Secondary outcome measures (7)
- Overall response rate （ORR） [Time frame: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion]
- Complete response rate (CRR) [Time frame: 12 months after CT119X infusion]
- Duration of remission(DOR) [Time frame: 12 months after CT119X infusion]
- Time to response (TTR) [Time frame: 12 months after CT119X infusion]
- Time to complete response (TTCR) [Time frame: 12 months after CT119X infusion]
- Progression-free survival (PFS) [Time frame: 12 months after CT119X infusion]
- Overall survival (OS) [Time frame: 12 months after CT119X infusion]
Eligibility criteria
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;
- 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;
- Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
- Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Tongji Hospital — Shanghai
Identifiers
NCT: NCT07043218 · CT119X-CG11004