Clinical trial · Interventional
A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma
A Study Evaluated Efficacy and Safety of CD19/22 Chimeric Antigen Receptor T Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT04539444CI-TRIAL-00113356completedPhase 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 center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19/22 CART | Biological | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19/22 CART cells combined with PD-1 inhibitors
- description
- Patients will receive PD-1 inhibitor on the first day after CART cell infusion
- interventionNames
- Biological: CD19/22 CART
- Drug: Tislelizumab
Primary outcomes (2)
- measure
- Overall response rate (ORR)
- timeFrame
- 1 year
- description
- Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.
- measure
- Progression-free survival(PFS)
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions): A.The lesion shrinkage \<50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen 2. Age ≥ 18 years 3. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points 4. The main organ functions need to meet the following conditions: A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 \> 90% 5. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion 6. Expected survival exceeds 3 months 7. Written informed consent could be acquired Exclusion Criteria: 1. Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years 2. Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection 3. Active hepatitis B or hepatitis C infection 4. HIV infection 5. Severe acute or chronic graft-versus-host disease (GVHD) 6. Participated in any other drug research clinical trials within 30 days before enrollment 7. Prior CART cells therapy within 3 months before enrollment 8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment 9. Have contraindications to the PD-1 inhibitors 10. Uncontrolled other tumor 11. Women in pregnancy,lactation or planning to become pregnant 12. The researcher considers inappropriate to participate in this research
References
Publications (0)
Data not yet available
No reference posted for this study.