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New treatment option for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Official title Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
ClinicalTrials.gov ID: NCT07523555
What this study is testing
What is Autologous CD19/CD22 dual-target CAR-T module?
Autologous CD19/CD22 dual-target CAR-T module is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory 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
- Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7.
- 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 75
You may be able to join if
- Age 18 to 75 years at the time of consent.
- Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk...
- Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the...
- Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety...
- Measurable or otherwise evaluable disease by disease-specific response criteria.
You likely can't join if
- \- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
- Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the...
- Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \>= Grade 3 toxicity from prior anticancer therapy
- Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
- Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled...
- Prior solid organ transplant.
See the full eligibility criteria
- Age 18 to 75 years at the time of consent.
- Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.
- Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.
- Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.
- Measurable or otherwise evaluable disease by disease-specific response criteria.
- ECOG performance status 0 to 2.
- Adequate organ function: LVEF \>= 45%; creatinine clearance \>= 40 mL/min; AST/ALT \ = 92% on room air.
- Adequate hematologic reserve unless cytopenia is clearly disease-related.
- Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.
- If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.
- Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.
- Written informed consent obtained before any study-specific procedure.
- \- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
- Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.
- Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \>= Grade 3 toxicity from prior anticancer therapy
- Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
- Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy.
- Prior solid organ transplant.
- Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.
- Uncontrolled HIV, HBV, or HCV viremia.
- Pregnancy or breastfeeding.
- Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.
- Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.
- Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.
- Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, 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.