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

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

NCT07476027•Institute of Hematology & Blood Diseases Hospital, China

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.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.

Key Dates

Start Date

March 15, 2026

Primary Completion Date

April 1, 2029

Completion Date

June 27, 2029

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

T Lymphoblastic LymphomaT Acute Lymphoblastic Leukemia

Interventions

CD7 CAR-T cell intravenous infusion

BIOLOGICAL

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

NCT00501826

T Acute Lymphoblastic LeukemiaT Lymphoblastic Lymphoma

View study

RECRUITINGPHASE1/PHASE2

211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia

NCT03128034

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome+10 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia

Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma