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RecruitingEarly Phase 1NCT06696833

Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Assessment of the Safety and Efficacy of Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia: A Single-Arm, Open-Label, Prospective Study

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

18 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Summary

This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed/refractory B-ALL

Eligibility

Min Age: 14 Years

Inclusion Criteria11

  • Age ≥14 years, gender not specified;
  • Diagnosed with B-ALL according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);
  • Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory B-ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells \>5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy；those with positive measurable residual disease can also be included；
  • Flow cytometry confirms positive CD19 expression in leukemia cells；
  • Estimated survival \>3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  • The vital organs function in accordance with the following requirements:
  • Left ventricular ejection fraction (LVEF) ≥50%; 7.2Pulmonary function：normal oxygen saturation without oxygen supplementation; 7.3Total bilirubin (TBil) ≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN； 7.4Creatinine ≤1.5×ULN;
  • Pregnancy test must be negative, and fertile non-abstinent female patients must agree to use effective contraception from the start of self-screening to 1 year after cell infusion. Fertile male patients with fertile partners must agree to use effective contraception from the start of self-screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study period；
  • No obvious hereditary diseases；
  • The subject and their legal guardian voluntarily participate in this study, understand the trial information and objectives, and provide informed consent with a signed and dated signature.

Exclusion Criteria10

  • Patients with severe autoimmune diseases or immunodeficiency diseases;
  • Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;
  • Any unstable diseases occurring within screening period (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.
  • Active graft-versus-host disease requiring continued systemic therapy;
  • The presence of anti-FMC63 and a positive DSA reaction;
  • Patients who have previously received CAR-T cell therapy within 6 months or donor lymphocyte infusion within 6 weeks before screening;
  • History of or concomitant active malignant tumors, excluding cured non-invasive basal cell or squamous cell skin cancer, uterine cervical carcinoma in situ or localized prostate cancer or breast ductal carcinoma in situ without recurrence for at least 2 years;
  • Presence of other severe medical conditions as determined by the investigator, such as uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.;
  • Other severe or persistent active infections;
  • Other conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Interventions

BIOLOGICALQH10304-BAL-01

dose escalation (3+3) : dose 1 (3 × 10\^8cells/kg) ,dose 2 (1 × 10\^9 cells/kg) ,dose 3 (3 × 10\^9cells/kg)

DRUGFludarabine

Intravenous fludarabine 30mg/m2 on days-6 to -3,the infusion dose is adjusted according to the subject's condition

DRUGCyclophosphamide

Intravenous cyclophosphamide 1000mg/m2 on days -5 to -3, the infusion dose is adjusted according to the subject's condition

Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, China, Jiangsu, China

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NCT06696833