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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;