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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07575971
What this study is testing
What is CD22/CD19 Dual-Target CAR-T Cells?
CD22/CD19 Dual-Target CAR-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
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 single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22/CD19 dual-target chimeric antigen receptor T-cell (CAR-T) therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first remission after standard induction therapy and consolidation chemotherapy. Approximately 30 patients will be enrolled.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment...
- Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) according to WHO 2022 criteria, with...
- Patients who are eligible for enhanced consolidation therapy. Patients with high-risk disease defined as: High-risk group based on cytogenetic and...
- Age between 18 and 85 years, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
You likely can't join if
- Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic...
- Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
- Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous...
- Non-disease-related hepatic or renal dysfunction defined as: ALT or AST \>3×ULN; Total bilirubin \>2×ULN; Creatinine clearance \<30 mL/min.
- History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable...
- Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled...
See the full eligibility criteria
- Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment, laboratory tests, and other study-related assessments.
- Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) according to WHO 2022 criteria, with CD19-positive and/or CD22-positive disease. Patients must have...
- Patients who are eligible for enhanced consolidation therapy. Patients with high-risk disease defined as: High-risk group based on cytogenetic and molecular features, regardless of MRD status after consolidation; or...
- Age between 18 and 85 years, regardless of sex.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Estimated life expectancy ≥3 months.
- Hemoglobin ≥60 g/L (transfusion allowed).
- Absolute neutrophil count ≥1,000/μL and platelet count ≥45,000/μL.
- Adequate organ function, defined as: Total bilirubin ≤1.5 × upper limit of normal (ULN) (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min...
- people of reproductive potential must agree to use effective contraception from enrollment until at least 6 months after completion of the study. people who are pregnant or suspected to be pregnant must notify the...
- Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation (meeting any of the following), who are...
- Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
- Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics. (Active HBV infection is defined as: HBV DNA ≥2000 IU/mL, ALT...
- Non-disease-related hepatic or renal dysfunction defined as: ALT or AST \>3×ULN; Total bilirubin \>2×ULN; Creatinine clearance \<30 mL/min.
- History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.
- Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary...
- History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.
- Pregnant or breastfeeding women.
- Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.
- History of other malignancies unless disease-free for at least 3 years without active treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ).
- Receipt of live vaccines within 6 weeks prior to initiation of lymphodepleting chemotherapy.
- Major surgery within 14 days prior to enrollment or planned major surgery during the study period.
- Any other condition that, in the investigator's judgment, may increase risk, interfere with study results, or make the patient unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.