Status:
UNKNOWN
Addition of Nivolumab to Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive DLBCL at Lymphodepletion
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, afte...
Detailed Description
Factors that may introduce resistance to CAR-T. in addition to the bulk of disease, include also expression of check point molecules that eventually interfere with the CAR-T action. The investigator, ...
Eligibility Criteria
Inclusion
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
- DLBCL treated with CAR-T targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel)
- PD/SD by PET-CT on the day of lymphodepletion
- Capable of giving signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No active CRS or ICANS at time of nivolumab administration
Exclusion
- Hypersensitivity to checkpoints inhibitors
- CRS grade 3 and above or ICANS any grade on days 0-5 following CAR-T
- AST (Aspartate transaminase) or ALT (Alanine transaminase) over 3 times the upper limit of normal (ULN) or total bilirubin over 3 times ULN
- Serum creatinine over 1.5 times ULN or over 1.5 times baseline
- History of or active autoimmune disease
- Uncontrolled seizure activity and/or clinically evident progressive encephalopathy
- Active diarrhea (more than 4 bowel movements per day)
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
- Other active malignancy
- Females only: Pregnant or breastfeeding
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05385263
Start Date
May 11 2022
End Date
October 1 2024
Last Update
May 26 2022
Active Locations (1)
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1
Tel-Aviv Sourasky Medicak center / BMT Unit
Tel Aviv, Israel, 6423906