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A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma


Trial ID:NCT02601313

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Protocol #:16-134


Principal Investigator:Caron Jacobson. M.D

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

Kathleen McDermott, Dana-Farber Cancer Institute,

Conducting Institutions:
Dana-Farber Cancer Institute
Brigham and Women's Hospital

Eligibilty Requirements:
Key Inclusion Criteria:

- Pathologically confirmed MCL

- 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

- Relapsed or refractory disease, defined by the following:

- Disease progression after last regimen, or

- Refractory disease is defined failure to achieve a PR or CR to the last regimen

- At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma

- Age 18 years or older

- Eastern cooperative oncology group (ECOG) performance status of 0 or 1

- ANC ≥ 1000/µL

- Platelet count ≥ 50,000/µL

- Adequate renal, hepatic, and cardiac function defined as:

- Serum creatinine ≤ 1.5 mg/dL

- Serum ALT/AST ≤ 2.5 ULN

- Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome.

- Cardiac ejection fraction ≥ 50% (by ECHO) and no evidence of pericardial effusion as determined by an ECHO.

Key Exclusion Criteria:

- History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years

- History of allogeneic stem cell transplantation

- Prior CD19 targeted therapy

- Prior CAR therapy or other genetically modified T cell therapy

- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)

- Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases

- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement