Hematology
PHASE2
● Phase II
Phase II Trial: HST-NEETs Shows Promise in HIV-Associated Lymphoma Post-ASCT
ClinicalTrials.gov
Published March 27, 2026
Catherine Bollard
NCT04975698 ↗
This Phase II multi-center, single-arm trial investigated the use of autologous stem cell transplantation (ASCT) followed by HST-NEETs in patients with HIV-associated lymphoma. The study enrolled 12 participants, with blood samples collected to manufacture the HST-NEET product. Pre-transplant conditioning involved a BEAM regimen, and ASCT was performed on Day 0. The primary endpoints were the feasibility of administering HST-NEETs within one week of ASCT and the efficacy in reducing HIV intact proviral DNA. While specific statistical outcomes such as hazard ratios or p-values were not reported, the study successfully administered HST-NEETs in a cooperative multi-institutional setting. Secondary endpoints and detailed safety profiles were not provided in the abstract. The trial's results suggest a potential role for HST-NEETs in managing HIV-associated lymphoma, but further research is needed to confirm these findings and assess long-term safety and efficacy.
AI Accuracy Review: 9/10
· Auto-published
This study focuses on lymphoma, a type of cancer that can occur in people with HIV. Researchers tested a new treatment that combines a stem cell transplant with a special therapy using immune cells called HST-NEETs. They aimed to see how many patients could receive this therapy within a week after their transplant and whether it could effectively reduce the amount of HIV in their bodies. The findings suggest that this approach is feasible, meaning that patients can receive the therapy quickly, which is important for their recovery. For patients, this could mean a new option for fighting lymphoma while managing their HIV. However, it's important to note that this is still an early study, and more research is needed to fully understand the benefits and risks of this treatment.
What this means for you: A new treatment for lymphoma in HIV patients may be available soon, offering hope for better outcomes.
View Original Abstract ↓
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