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CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia

RecruitingPhase 2Ages 14 Years - 85 YearsAllBeijing Tongren Hospital
NCT06081478 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 14 years to 85 years, expected survival \> 3 months; * CD19/CD22 positive B-cell lymphoma or B-ALL; * relapsed or refractory to standard first-line treatment; * ECOG-PS score=0-2; * Having at least one measurable lesions; * Cardiac function: 1-2 levels; * Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; * kidney: Cr≤1.25ULN; * bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L; * No serious allergic constitution; * No other serious diseases that conflicts with the clinical program; * No other cancer history; * No serious mental disorder; * Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: * Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); * Uncontrolled active infection, HIV infection, syphilis serology reaction positive; * Active hepatitis B or hepatitis C infection; * Recent or current use of glucocorticoid or other immunosuppressor; * With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * Participate in other clinical research in the past three months; * previously treatment with any gene therapy products; * Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
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What it tests

  • CD19/CD22-bispecific CAR-T cells
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Where

1 site
Liang Wang
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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