Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL

NCT07476027 — Early Phase 1, Not yet recruiting, 10 participants, Institute of Hematology & Blood Diseases Hospital, China

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Efficacy and Safety of CD7 CAR-T Cell in Newly Diagnosed High-Risk T-LBL/ALL

Registry	NCT07476027
Status	Not yet recruiting
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Estimated)
Sponsor	Institute of Hematology & Blood Diseases Hospital, China (Other)
Conditions	T Lymphoblastic Lymphoma, T Acute Lymphoblastic Leukemia
Interventions	CD7 CAR-T cell intravenous infusion (Biological)
Dates	start 2026-03-15 (estimated), primary completion 2029-04-01 (estimated), completion 2029-06-27 (estimated), first posted 2026-03-17, last updated 2026-03-17

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
CD7 CAR-T cell injection	Experimental	Biological: CD7 CAR-T cell intravenous infusion

CD7 CAR-T cell intravenous infusion (Biological): CD7 CAR-T cells, single intravenous infusion

+Outcome measures

Primary outcomes

CR Rate [28 days after CD7 CAR-T cell infusion]: CR+CRi

+Eligibility

Sex: All, ages: any to 18 Years

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 \[positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center\].
* Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.).
* A history of severe hypersensitivity to biological products (including antibiotics).
* Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
* Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.