Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL (NCT07476027) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL
10 participantsStarted 2026-03-15
Plain-language summary
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.
Who can participate
Age range
18 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:
* Patients aged ≤18 years with newly diagnosed T-LBL/ALL.
* Have completed induction chemotherapy and achieved CR1, with bone marrow MRD \< 0.01%.
* High/very high-risk or poor induction response patients.
* High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation.
* Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80).
* Legal guardian agrees to provide written informed consent.
Infusion Criteria:
* Essential normal function of major organs.
* Left ventricular ejection fraction (LVEF) ≥ 45%.
* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age.
* Serum total bilirubin, ALT/AST ≤ 3 × ULN (unless clearly related to leukemic infiltration).
* No active, uncontrolled severe infection.
Exclusion Criteria:
* Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment.
* Complicated with other progressive malignant tumors.
* Presence of active and/or uncontrolled infections that have not been effectively managed.
* Complicated with severe autoimmune diseases or congenital immunodeficiency.
* Active hepatitis \[positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than…
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
CR Rate
Timeframe: 28 days after CD7 CAR-T cell infusion
Trial details
NCT IDNCT07476027
SponsorInstitute of Hematology & Blood Diseases Hospital, China