CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

Inclusion criteria

• Histologically or cytologically confirmed relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), nodal T-cell lymphomas with T-follicular helper (TFH) phenotype, including follicular T cell lymphoma, angioimmunoblastic lymphoma, or anaplastic large cell lymphoma) or other non-leukemic CD5+ aggressive mature T cell lymphomas (such as enteropathy-associated T cell lymphoma, monomorphic epitheliotropic intestinal T cell lymphoma, transformed mycosis fungoides, primary cutaneous aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma, primary cutaneous insert gamma delta symbols lymphoma, or subcutaneous panniculitis like T cell lymphoma).
• ≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy
• Must have received at least one line of prior systemic therapy for their lymphoma; participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab.
• Evaluable disease defined by at least one lesion that can be measured in least 1 dimension and measures at least 1.5 cm in its longest dimension by CT or PET scan, or bone/bone marrow involvement, or skin involvement.
• No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.

Exclusion criteria

• Pregnant or lactating (nursing) women.
• HIV infection.
• Concurrent use of systemic steroids or immunosuppressant medications.
• Any uncontrolled active medical disorder that would preclude participation as outlined.
• History of immunodeficiency.
• History of prior chimeric antigen receptor therapy (CAR T), autologous or syngeneic HCT <100 days from transplant at the time of cell infusion or previous allo-HCT.
• Active and/or systemic inflammatory or autoimmune diseases.
• Signs or symptoms indicative of active CNS involvement.
• Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to lymphoma or previous lymphoma treatment.
• Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management
• Current participation in or prior participation in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment.
• Prior monoclonal antibody therapy within 4 weeks prior to study Day 1
• Prior use of alemtuzumab
• Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
• Uncontrolled active infection requiring systemic therapy.
• Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present.
• Active and/or systemic inflammatory or autoimmune diseases.