Clinical trial · Interventional
Safety and Efficiency Study of CD19-PD1-CART Cell in Relapsed/Refractory B Cell Lymphoma
NCT04163302CI-TRIAL-00041666unknownPhase 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-PD1-CART 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-PD1-CART Cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19+ Lymphoma
- description
- This study is to evaluate the efficacy and safety of CD19-PD1-CART cells therapy for patients with Relapsed/Refractory B Cell Lymphoma.
- interventionNames
- Biological: CD19-PD1-CART Cell
Primary outcomes (1)
- measure
- Incidence of Treatment-related Adverse Events
- timeFrame
- 3 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 4.0).
Secondary outcomes (5)
- measure
- Overall Remission Rate(ORR) of CD19-PD1-CART cells in Lymphoma
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, aged 14 to 80 years (including 14 and 80 years old). 2. The diagnosis was Refractory/relapsed B-cell lymphoma.(Meeting 1 of the first 4 items plus item 5) A.Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy. B.Achieved CR after standard chemotherapy, but relapsed within 6 months. C.2 or more relapses after CR. D.Not suitable for HSCT, or relapse after HSCT. E.Subjects must have received adequate treatment in the past and the predicted survival is more than three months. 3. Patient or his or her legal guardian voluntarily participates in this stuy and signs an informed consent form. 4. Flow cytometry or immunohistochemistry showed CD19 positive in tumor cells. 5. No serious concomitant disease and major organ function is not serious abnormal. 6. ECOG physical condition score 0-3 or KPS score \> 80. 7. the test meets the following indicators: A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L. B.Creatinine \< 176.8 μmol/L. C.WBC≥2.5×109/L ,LY≥0.7×109/L,LY%≥15%. D.PT/INR \< 1.7 or PT was extended by less than 4 seconds. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Patients whose tumor cell don't have positive CD19 antigen. 3. Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection. 4. Patients who are using steroid drugs throughout the body currently. 5. Patients who have received any gene therapy in the past. 6. Patients who are allergy to immunotherapy and related drugs. 7. Patients with heavy heart disease or poorly controlled high blood pressure. 8. Patients who received chemotherapy or radiation 4 weeks before the study began. 9. Patients who are participating in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.