Clinical trial · Interventional
Addition of Nivolumab to Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive DLBCL at Lymphodepletion
Addition of Nivolumab to Standard of Care With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive DLBCL at Lymphodepletion
- 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)
Progression of DLBCL is the major obstacle for the success of chimeric antigen receptor-T cell (CAR-T) with approximately 60% of the patients relapsing in the first year, and 40% within 3 months, after infusion. While patient with DLBCL in Partial Response/Complete Response at lymphodepletion have a 1-year Progression Free Survival (PFS) of 60-80%, those with Stable Disease/Progressive Disease at time of lymphodepletion have a dismal PFS of 20-30%. Trials showed that better expansion of CAR-T cells, even in patients with a progressive disease, may overcome this grave prognosis and may result in better PFS
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 |
|---|---|---|---|
| Nivolumab Injection [Opdivo] | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIVOLUMAB
- description
- All patients enrolled will be given nivolumab ( 3mg/kg IV) on day +5 Patients with CAR-T expansion\<100 cells/microL on day +7 will be given 1 additional dose of nivolumab (3mg/kg IV) on day +19 (two weeks after first dose of nivolumab).
- interventionNames
- Drug: Nivolumab Injection [Opdivo]
Primary outcomes (1)
- measure
- Overall response at 1 months after CAR-T infusion
- timeFrame
- One month post CAR-T infusion
- description
- Complete or partial remission rate assessed by PET-CT (Positron Emission Tomography ) at 1 month after combination therapy with nivolumab and CAR-T.
Secondary outcomes (5)
- measure
- Overall survival at 1 year after CAR-T infusion and nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. 2. DLBCL treated with CAR-T targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) 3. PD/SD by PET-CT on the day of lymphodepletion 4. Capable of giving signed informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. No active CRS or ICANS at time of nivolumab administration Exclusion Criteria: 1. Hypersensitivity to checkpoints inhibitors 2. CRS grade 3 and above or ICANS any grade on days 0-5 following CAR-T 3. AST (Aspartate transaminase) or ALT (Alanine transaminase) over 3 times the upper limit of normal (ULN) or total bilirubin over 3 times ULN 4. Serum creatinine over 1.5 times ULN or over 1.5 times baseline 5. History of or active autoimmune disease 6. Uncontrolled seizure activity and/or clinically evident progressive encephalopathy 7. Active diarrhea (more than 4 bowel movements per day) 8. Clinically significant uncontrolled illness 9. Active infection requiring antibiotics 10. Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection 11. Other active malignancy 12. Females only: Pregnant or breastfeeding
References
Publications (1)
- DERIVEDRam R, Amit O, Perry C, Herishanu Y, Avivi I, Sarid N, Apel A, Preis M, Aviv A, Shapira S, Shragai T, Joffe E, Shargian L, Herzog-Tsarfati K, Eylati N, Acria L, Fridberg G, Gold R, Glait-Santar C, Kay S, Gal-Rabinovich K, Rosenberg D, Setter-Marco N, Beyar-Katz O. Addition of Nivolumab Tailored by Expansion of CAR-T Cells in Patients with Stable/Progressive Large B Cell Lymphoma at Lymphodepletion-A Phase 2, Prospective Interventional Study. Transplant Cell Ther. 2024 Dec;30(12):1178-1188. doi: 10.1016/j.jtct.2024.09.024. Epub 2024 Oct 11. PMID 39396632