Infusion therapy using CAR-γδT cells for treating relapsed B-Cell 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

This study is testing a new treatment using special immune cells to see if it can help people with relapsed B-Cell leukemia who haven't responded to other therapies.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Suzhou, China, Jiangsu)
• Trial ID: NCT06696833 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of allogeneic CD19-targeted CAR-γδT cell infusion therapy for patients with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL). The primary objective is to assess the safety and determine the optimal dosage for future studies, while the secondary objective focuses on evaluating the treatment's efficacy. Participants will receive a combination of CAR-γδT cells along with Fludarabine and Cyclophosphamide as part of the intervention. The study aims to provide a new therapeutic option for patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 14 and older diagnosed with relapsed or refractory B-ALL that expresses CD19.

Not a fit: Patients with isolated extramedullary relapse or those who do not express CD19 on their leukemia cells may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment option for patients with relapsed or refractory B-ALL, potentially improving survival rates.

How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results in treating B-ALL, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥14 years, gender not specified;
2. Diagnosed with B-ALL according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);
3. 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；
4. Flow cytometry confirms positive CD19 expression in leukemia cells；
5. Estimated survival \>3 months;
6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
7. The vital organs function in accordance with the following requirements:

   7.1Left 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;
8. 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；
9. No obvious hereditary diseases；
10. 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 Criteria:

1. Patients with severe autoimmune diseases or immunodeficiency diseases;
2. 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.;
3. 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.
4. Active graft-versus-host disease requiring continued systemic therapy;
5. The presence of anti-FMC63 and a positive DSA reaction;
6. Patients who have previously received CAR-T cell therapy within 6 months or donor lymphocyte infusion within 6 weeks before screening;
7. 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;
8. Presence of other severe medical conditions as determined by the investigator, such as uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.;
9. Other severe or persistent active infections;
10. Other conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Where this trial is running

Suzhou, China, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, China, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D

Conditions: B-Cell Acute Lymphoblastic Leukemia, Adult, B-ALL