Phase II Trial: HST-NEETs Shows Promise in HIV-Associated Lymphoma Post-ASCT

Status: COMPLETED | Phase: PHASE2 Condition(s): HIV Associated Lymphoma Intervention(s): HST-NEETs (BIOLOGICAL), Bone Marrow Transplant (BIOLOGICAL) This is a Phase II multi-center trial single arm trial of autologous transplantation (ASCT) followed by administration of HST-NEETs for treatment of HIV associated lymphoma Detailed: Eligible participants will have 100-120 mL of peripheral blood or 80-100 mL of MNCs via apheresis collected and shipped to Children's National Hospital at ambient temperature. The sample will be used to manufacture the HST-NEET product. The autologous peripheral blood stem cell graft suitable for rescue following conditioning will be obtained either before or after the collection of blood to generate HST-NEETs. Pre-transplant conditioning will consist of BEAM; BCNU 300 mg/m\^2 on Day -6, Etoposide 100 mg/m\^2 BID and Ara-C 100 mg/m2 BID on Days -5, -4, -3 and -2 and Melphalan 140 mg/m2 on Day -1. ASCT on Day 0. If the mobilized graft contains greater than 5.0 x 106 CD34+ cells per kg, any additional cells should be cryopreserved as a "back-up" graft in the event of graft failure related to Primary Outcome(s): To determine 1.) the proportion of participants who can be treated with (HST-NEETs) within 1 week of ASCT in a cooperative multi-institutional setting and 2.) the efficacy of HSTNEETs in reducing the HIV intact proviral Enrollment: 12 (ACTUAL) Lead Sponsor: Catherine Bollard Start: 2021-10-25 | Primary Completion: 2025-11-24