Clinical trial · Interventional
Cytoplasmic Activated PD-1 CAR T Cells in Refractory/Relapsed B Cell Lymphoma
Phase Ⅰ Study of CAR19 T Cells Carrying Cytoplasmic Activated PD-1 in the Treatment of Refractory/Relapsed B Cell Lymphoma
NCT03540303CI-TRIAL-00033131unknownPhase 1ClinicalTrials.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)
Evaluation of the safety and efficacy of CAR19 T cells carrying cytoplasmic activated PD1 in patients with refractory relapsed 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 |
|---|---|---|---|
| Relapsed Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR19 T cells carrying cytoplasmic activated PD-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR19 T cells carrying cytoplasmic activated PD-1
- description
- patients with refractory/relapsed B-NHL receive a preconditioning before infusion of CAR T cells.
- interventionNames
- Drug: CAR19 T cells carrying cytoplasmic activated PD-1
Primary outcomes (1)
- measure
- safety: occurrence of study related adverse events
- timeFrame
- 6 months
- description
- occurrence of study related adverse events
Secondary outcomes (1)
- measure
- objective response rate
- timeFrame
- 3 months and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years old and the expected lifetime \>3 months * Refractory/relapsed CD19 positive B cell lymphoma by pathology * ECOG score \<2 * Measureable lesions according to RECIST 1.1 * Sufficient heart, liver, kidney and bone marrow function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN; bone marrow: WBC ≥ 2.0 × 109/L, Hb ≥ 80 g/L, PLT ≥ 30 × 109/L) * no serious allergies * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation) * No other history of malignancy * No serious mental disorders * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study * The patient himself agrees to participate in this clinical study and signed the "informed consent" Exclusion Criteria: * Lactating women * Severe infectious or viral diseases (HIV positive, syphilis, etc.) * Active hepatitis B or C viral hepatitis * Patients who used high-dose glucocorticoids within 1 week * Participation in other clinical studies in the past 3 months or having been treated with other gene products
References
Publications (0)
Data not yet available
No reference posted for this study.