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To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT | Clinical Trials | Clareo Health

RECRUITINGPHASE1

To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT

An Open-label, Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Measurable Residual Disease of T-lymphoblastic Leukaemia/Lymphoma Post Allogeneic Stem Cell Transplantation

NCT07280494•Peking University People's Hospital

View on ClinicalTrials.gov

Summary

To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation

Detailed Description

This study will explore the efficacy and safety of a natural selection-targeted CD7 CART cell therapy for measurable residual disease after allogeneic hematopoietic stem cell transplantation in T-ALL/LBL. The dose of targeted CD7 CART cells is 2E6 cells/kg, with a single infusion.

Eligibility

Age

3 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).
•(2) Male or female, age ≥ 3 years at the time of signing the informed consent form.
•(3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed/refractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria:
•1. Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow \< 5%, and positive for minimal residual disease of leukemia/lymphoma determined by flow cytometry.
•2. Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.
•(6) Major organ functions must meet the following requirements:
•
•1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
•2. Total bilirubin ≤ 2× ULN.
•3. For adult subjects, the serum creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg/dL for 2 to 6 years old, 1.0 mg/dL for 6 to 10 years old, 1.2 mg/dL for 10 to 13 years old, 1.5 mg/dL for 13 to 16 years old males, and 1.4 mg/dL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg/dL.
+2 more criteria

Exclusion Criteria

•Subjects with any of the following conditions will not be eligible for inclusion in this study.
•1. A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.
•2. Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
•3. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.
•4. Clinically significant cardiovascular diseases, including any of the following:
•1. Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
•2. New York Heart Association (NYHA) class II or higher heart failure;
•3. Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
•4. Left ventricular ejection fraction (LVEF) \< 50%;
•5. Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
+14 more criteria

Locations (1)

Peking University People's Hospital

Beijing, China, China

Key Dates

Start Date

August 18, 2025

Primary Completion Date

August 30, 2026

Completion Date

December 31, 2027

Last Updated

December 12, 2025

Enrollment

ESTIMATED participants

Conditions

CD7+ T-ALL/LBL

Interventions

CAR-T Therapy

DRUG

Contacts

Jing Liu

CONTACT

8610-88326900 greenimp@163.com

Na Kuang

CONTACT

86-18630160116 kuangna@senlangbio.com