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 range18 Years
SexALL
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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…
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