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A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2)

Enrolling

Trial ID:NCT02601313

View complete trial on ClinicalTrials.gov

Protocol #:16-134

DiseasesNon-Hodgkin's Lymphoma

Phase:II

Principal Investigator:Jacobson, Caron, A

Trial Description:
Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed / Refractory MCL

Eligibilty Requirements:
Key Inclusion Criteria:

Up to 5 prior regimens for MCL. Prior therapy must have included:

- Anthracycline or bendamustine-containing chemotherapy and

- Anti-CD20 monoclonal antibody therapy and

- Ibrutinib or acalabrutinib

At least 1 measurable lesion

Platelet count ≥ 75,000/uL

Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings

Baseline oxygen saturation >92% on room air.

Key Exclusion Criteria:

- Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing

- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement

- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.