Clinical trial · Interventional
CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma
CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large B-Cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19/CD22 bispecific CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19/CD22 CAR-T group
- description
- Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg.
- interventionNames
- Drug: CD19/CD22 bispecific CAR-T cells
Primary outcomes (1)
- measure
- best overall response rate (ORR) as of 3 months post-CAR-T cells infusion
- timeFrame
- From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
- description
- Overall response rate means sum of complete response rate and partial response rate
Secondary outcomes (4)
- measure
- Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
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