Clinical trial · Interventional
Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
NCT05651100CI-TRIAL-00062677unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory 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 |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 and CD22 targeted CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- arm 1
- description
- sequential CD19 and CD22 targeted CAR-T cells treat
- interventionNames
- Biological: CD19 and CD22 targeted CAR-T cells
Primary outcomes (2)
- measure
- Adverse events that related to treatment
- timeFrame
- 1 years
- description
- Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
- measure
- Overall remission rate (ORR)
- timeFrame
- 3 months
- description
- The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed or refractory B cell non-hodgkin lymphoma. 2. KPS\>60. 3. Life expectancy\>12 weeks. 4. Gender unlimited, age from 3 years to 70 years. 5. Evidence for cell membrane CD19 and/or CD22 expression; 6. Patients who have failed at least one line of a standard treatment. 7. No serious mental disorder. 8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L). 9. No other serious diseases(autoimmune disease, immunodeficiency etc.). 10. No other tumors. 11. Patients volunteer to participate in the research. 12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial Exclusion Criteria: 1. Pregnancy and nursing females. 2. Patients are allergic to cytokines. 3. Uncontrolled active infection. 4. Acute or chronic GVHD. 5. Treated with T cell inhibitor. 6. Patients who had used steroid hormones within one week. 7. Patients who had used Rituximab within two weeks. 8. HIV/HBV/HCV Infection. 9. Other situations we think improper for the research.
References
Publications (0)
Data not yet available
No reference posted for this study.