Study on the Effectiveness and Safety of JCAR017 for Adults with Relapsed or Hard-to-Treat Indolent B-cell Non-Hodgkin Lymphoma

Inclusion Criteria

• Have a confirmed diagnosis of relapsed or hard-to-treat follicular lymphoma (FL) or marginal zone lymphoma (MZL) within the last 6 months.
• Have received at least one previous treatment that included anti-CD20 and an alkylating agent.
• For follicular lymphoma patients: Must have had at least one previous systemic treatment. If only one treatment was received, the patient must have high-risk features. If two or more treatments were received, one must have included anti-CD20 and an alkylating agent.
• For marginal zone lymphoma patients: Must have had two or more previous systemic treatments, including anti-CD20 and an alkylating agent, or have relapsed after a stem cell transplant.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function.
• Have suitable veins for the leukapheresis procedure.

Exclusion Criteria

• Have a history or evidence of a more aggressive type of lymphoma or transformed follicular lymphoma.
• Have a specific type of follicular lymphoma affecting the duodenum.
• Have cancer that only affects the central nervous system (CNS), although those with secondary CNS involvement can participate.
• Have had another primary cancer that has not been in remission for at least two years, except for non-invasive cancers.
• Have previously received CAR T-cell or other genetically-modified cell therapy.
• Have a history of or active HIV.
• Have active hepatitis B or C.
• Have an uncontrolled infection despite treatment.
• Have an active autoimmune disease requiring immunosuppressive therapy.
• Have graft-versus-host disease.
• Have a history of significant heart disease.
• Have a history or presence of significant CNS issues.
• Have had a stem cell transplant from a donor within 90 days of the leukapheresis procedure.