Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
NCT ID: NCT06696833
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
EARLY_PHASE1
18 participants
INTERVENTIONAL
2024-12-01
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial
NCT06326008
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
NCT03263208
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma
NCT03110640
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL
NCT07008885
Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia
NCT05225831
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To assess the safety of allogeneic CD19-targeted CAR-γδT Cell in the treatment of relapsed/refractory B-ALL, and to determine the recommended dose (RP2D) for the phase II study.
Secondary Objective:
To evaluate the efficacy of allogeneic CD19-targeted CAR-γδT Cell in the treatment of relapsed/refractory B-ALL.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with relapsed/refractory B cell Acute lymphoblastic Leukemia
In this study, we adopted a 3+3 design with dose escalation. A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, and each dose group received treatment on Days 0 through i.v. injection, with bone marrow examination performed on Days 14 and 28 to assess tumor burden. Upon assessment by the investigators and discussion with the Safety Review Committee (SRC), it will be determined that whether patients may benefit from additional infusions. With SRC approval, the number of administrations could be increased. At the end of dose escalation, the SRC may decide to adjust the number of participants in the designated dose group as deemed appropriate.
QH10304-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)
Fludarabine
Intravenous fludarabine 30mg/m2 on days-6 to -3,the infusion dose is adjusted according to the subject's condition
Cyclophosphamide
Intravenous cyclophosphamide 1000mg/m2 on days -5 to -3, the infusion dose is adjusted according to the subject's condition
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QH10304-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)
Fludarabine
Intravenous fludarabine 30mg/m2 on days-6 to -3,the infusion dose is adjusted according to the subject's condition
Cyclophosphamide
Intravenous cyclophosphamide 1000mg/m2 on days -5 to -3, the infusion dose is adjusted according to the subject's condition
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaowen Tang, Ph.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Soochow University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Soochow University
Suzhou, China, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QH10304-BAL-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.