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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital

Criteria

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.