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