Clinical trial · Interventional
Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
Prospective, Multicenter, Open, One-arm Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
NCT05744037CI-TRIAL-00064244unknownPhase 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)
To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.
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 |
|---|---|---|---|
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| regimen with BTK inhibitor +Anti-CD19 CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T Cell Infusion
- description
- After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.
- interventionNames
- Biological: regimen with BTK inhibitor +Anti-CD19 CAR T cells
Primary outcomes (1)
- measure
- objective response rate
- timeFrame
- From 1 month to 1 year.
- description
- CR+PR
Secondary outcomes (3)
- measure
- Percentage of complete response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18-70 years old; 3. CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy; 4. Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy; 5. Have measurable or evaluable lesions; 6. The patient's main tissues and organs function well; 7. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip. 8. Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years. Exclusion Criteria: 1. Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding; 2. Men or women who have planned to get pregnant within the last 1 year; 3. The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, etc.) within 1 year after enrollment; 4. Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment; 5. Active hepatitis B/C virus; 6. HIV-infected patients; 7. Suffering from a serious autoimmune disease or immunodeficiency disease; 8. The patient is allergic to antibodies, cytokines and other macromolecular biological drugs; 9. The patient had participated in other clinical trials within 6 weeks prior to enrollment; 10. Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); 11. Suffering from mental illness; 12. The patient has substance abuse/addiction; 13. According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.