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

Recruiting now · Phase 1

Conditions studied: CD7+ T-ALL/LBL

In brief

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

Key facts

Study ID

NCT07280494

Run by

Peking University People's Hospital

People needed

18

Starts

2025-08-18

Expected to finish

2027-12-31

Last updated by the study team

2025-12-12

Who can join

Age: 3 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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:
• 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.
• 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:
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• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
• Total bilirubin ≤ 2× ULN.
• 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.
• If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator.
• (7) Blood oxygen saturation > 92%. (8) Male subjects with reproductive capacity and female subjects of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 2 years after the use of the study drug. Female subjects of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of female subjects of childbearing age at screening must be negative.

You may not qualify if…

• Subjects with any of the following conditions will not be eligible for inclusion in this study.
• 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.
• Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
• 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.
• Clinically significant cardiovascular diseases, including any of the following:
• Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
• New York Heart Association (NYHA) class II or higher heart failure;
• Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
• Left ventricular ejection fraction (LVEF) < 50%;
• Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
• Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
• Allergy to any component of the drugs to be used in this study.
• Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.
• Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.
• Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:
• Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);
• Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose;
• Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography [CT]);
• For the treatment of adverse reactions after reinfusion.
• Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.
• Had active tuberculosis infection within 1 year before signing the ICF (except for subjects with active tuberculosis infection more than 1 year ago and judged by the investigator to have no evidence of active tuberculosis at present).
• Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.
• The investigator believes that the subject's complications or other conditions may affect compliance with the protocol or are not suitable for participation in this study.
• Pregnant or lactating.

Where it is running

• Peking University People's Hospital — Beijing, China, China (enrolling)

Full record on ClinicalTrials.gov

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