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

NCT07476027 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IIT2026027
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

T Lymphoblastic Lymphoma; T Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• CR Rate

  CR+CRi

  28 days after CD7 CAR-T cell infusion

Study Arms (1)

CD7 CAR-T cell injection

EXPERIMENTAL

Biological: CD7 CAR-T cell intravenous infusion

Interventions

CD7 CAR-T cell intravenous infusion BIOLOGICAL

CD7 CAR-T cells, single intravenous infusion

CD7 CAR-T cell injection

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 27, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03