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

March 12, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD7 CAR-T cell injection
Biological: CD7 CAR-T cell intravenous infusion
CD7 CAR-T cells, single intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR Rate
Time Frame: 28 days after CD7 CAR-T cell infusion
CR+CRi
28 days after CD7 CAR-T cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

June 27, 2029

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2026027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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