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Completed NCT07461831

CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma

Conditions: Large B-Cell Lymphoma (LBCL)

Sex: All
Ages: 14 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 74
Sponsor: Beijing Tongren Hospital

Location: Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality

Summary

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, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.

Eligibility Criteria

Inclusion Criteria: * 14 years to 85 years, expected survival \> 3 months; * CD19 positive with or without CD22 positive Large B-cell lymphoma; * relapsed or refractory disease; * ECOG-PS score=0-2; * Having at least one measurable lesion; * 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; * With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * Participate in other clinical research in the past 4 weeks; * 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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07461831). StuddyBuddy aggregates publicly available trial information.