Spots Global Cancer Trial Database for HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903
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Trial Identification
Brief Title: HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903
Official Title: Administration of HIV-specific T Cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue - Auto -RESIST BMT CTN 1903
Study ID: NCT04975698
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Georgetown, Washington, District of Columbia, United States
Miami Cancer Institute, Miami, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Northside, Atlanta, Georgia, United States
University of Illinois, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Cornell, New York, New York, United States
Memorial Sloan Kettering (MSKCC), New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Baylor College of Medicine, Houston, Texas, United States
MD Anderson, Houston, Texas, United States
Contact Details
Name: Steve Devine, MD, MS
Affiliation: National Marrow Donor Program
Role: STUDY_CHAIR
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