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Recruiting Phase 1

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

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About this study

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

Condition
CD7+ T-ALL/LBL
Tested
CAR-T Therapy
Sponsor
Peking University People's Hospital

Who can join

Age
3 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 18

  • Minimum age: 3 years
  • Maximum age: 80 years
  • Study condition: CD7+ T-ALL/LBL
  • (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.

Exclusion 25

  • 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

1 site, 1 recruiting

Peking University People's Hospital

Beijing, China, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.