BridgeMD
New treatment option for B-Cell Acute Lymphoblastic Leukemia, Adult
Official title Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06696833
What this study is testing
What is QH10304-BAL-01?
QH10304-BAL-01 is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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...
- Flow cytometry confirms positive CD19 expression in leukemia cells；
- Estimated survival \>3 months;
You likely can't join if
- 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...
- Any unstable diseases occurring within screening period (including but not limited to): unstable angina, ischemic or cerebrovascular accidents...
- 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;
See the full eligibility criteria
- 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...
- 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: 7.1Left ventricular ejection fraction (LVEF) ≥50%; 7.2Pulmonary function：normal oxygen saturation without oxygen supplementation; 7.3Total...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, China, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, China, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.