NCT04975698

HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903

Administration of HIV-specific T Cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue - Auto -RESIST BMT CTN 1903

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Catherine Bollard · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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 description

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 the HST-NEETs. Participants will receive one dose (2 x 107 cells/m\^2 ) of HST-NEETs between Days +3 to +7 based on the clinical condition of the participant. If this window is missed, the HST-NEETs may be administered up to Day +30 post-ASCT. Participants will be followed for at least one year after ASCT.

Conditions

• HIV Associated Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	HST-NEETs	HST-NEETs are manufactured from an autologous peripheral blood or MNCs via apheresis collection and will be administered as a single intravenous (IV) infusion of 2x10\^7/m\^2 cells between 3 Days and 7 Days post-ASCT.
BIOLOGICAL	Bone Marrow Transplant	Day 0 is the day of bone marrow transplantation.

Timeline

• Start date: 2021-10-25
• Primary completion: 2025-11-24
• Completion: 2026-01-05
• First posted: 2021-07-23
• Last updated: 2026-03-25

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study