Clinical trial · Interventional
PD1-CD19-CART in Patients With r/r B-cell Lymphoma
a Safety and Efficacy Evaluation of PD1-CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma
NCT04213469CI-TRIAL-00072720completedN/AClinicalTrials.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 an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.
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 Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD1-CD19-CART
- description
- Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of PD1-CD19-CART will be infused on day 0.
- interventionNames
- Biological: PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells
Primary outcomes (2)
- measure
- MTD
- timeFrame
- up to 28 days after T cell infusion
- description
- MTD will be determined based on DLTs observed during the first 28 days of study treatment.
- measure
- RP2D
- timeFrame
- up to 28 days after T cell infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have the capacity to give informed consent; 2. ALL patients with the age between 18 and 70 years old; 3. Expected survival \>3 moths; 4. With no severe heart and lung disease; 5. Previously confirmed diagnosis as CD19+ NHL within 6 months; 6. Hematological index as following, white blood cell (WBC)≥1.5×10\^9/L,absolute neutrophil count (ANC) ≥0.8×10\^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10\^9/L; 7. Blood biochemical index as no more than 1.5\* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5\* ULN in patients with tumor metastasis in liver and kidney; 8. With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%; 9. Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test is acceptable if HBsAg is positive; 10. ECOG \<2; 11. Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after \> 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT. Exclusion Criteria: 1. Pregnant or lactating women; 2. With a pregnancy plan in the next 2 years; 3. Prior treatment of anti-GVHD therapy; 4. Acceptance of allogeneic stem cell transplant (ASCT); 5. Isolated extramedullary relapse of ALL; 6. Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases; 7. Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment; 8. History of other type of maligant tumors; 9. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.
References
Publications (4)
- DERIVEDHu Y, Zu C, Zhang M, Wei G, Li W, Fu S, Hong R, Zhou L, Wu W, Cui J, Wang D, Du B, Liu M, Zhang J, Huang H. Safety and efficacy of CRISPR-based non-viral PD1 locus specifically integrated anti-CD19 CAR-T cells in patients with relapsed or refractory Non-Hodgkin's lymphoma: a first-in-human phase I study. EClinicalMedicine. 2023 May 18;60:102010. doi: 10.1016/j.eclinm.2023.102010. eCollection 2023 Jun. PMID 37251628
- DERIVEDZhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16. PMID 37192741
- DERIVEDZhang J, Hu Y, Yang J, Li W, Zhang M, Wang Q, Zhang L, Wei G, Tian Y, Zhao K, Chen A, Tan B, Cui J, Li D, Li Y, Qi Y, Wang D, Wu Y, Li D, Du B, Liu M, Huang H. Non-viral, specifically targeted CAR-T cells achieve high safety and efficacy in B-NHL. Nature. 2022 Sep;609(7926):369-374. doi: 10.1038/s41586-022-05140-y. Epub 2022 Aug 31. PMID 36045296
- DERIVEDGolubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121. PMID 35468680