8/12-Day Production of Car-T Cells

A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

A fixed cryopreserved dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

This is a Phase 1/Phase 2 study. The objectives are as follows: 1. Phase 1: Determine the safety of a fixed dose of 2.5x10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15 in relapsed refractory B-cell NHL with flexible 8/12-day manufacturing and a fixed 12-day manufacturing process along with an evaluation in chronic lymphocytic leukemia (CLL) and central nervous system (CNS) lymphoma. 2. Phase 1b: Four arms: Arm A: 8/12 flexible manufacturing arm.

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Live record on ClinicalTrials.gov →

• GENERAL INCLUSION CRITERIA FOR ALL PATIENTS
• Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.
• Absolute cluster of differentiation 3 (CD3) count ≥50 mm\^3.
• Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment EXCEPT Arm E subjects.
• Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL and primary/secondary CNS lymphoma).
• Karnofsky performance score ≥70.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.