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

  • STATUS
    Recruiting
  • End date
    Jun 20, 2026
  • participants needed
    12
  • sponsor
    Catherine Bollard
Updated on 20 April 2022

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

Description

Eligible participants will have 100-120 mL of peripheral blood collected and shipped to Children's National Hospital at ambient temperature. The peripheral blood 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.

Details
Condition HIV Associated Lymphoma
Treatment busulfan, Bone Marrow Transplant, HST-NEETs
Clinical Study IdentifierNCT04975698
SponsorCatherine Bollard
Last Modified on20 April 2022

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