HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903
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
2 other identifiers
interventional
12
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2021
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2026
CompletedMarch 25, 2026
March 1, 2026
4.1 years
July 14, 2021
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Feasibility is defined as a participant receiving HST-NEETs within 1 week post-ASCT; Efficacy will be measured by the reduction in intact proviral reservoir.
6 Months
Secondary Outcomes (3)
Progression-free survival
6 Months and 1 Year
The incidence and severity of acute infusion related toxicities
1 Year
Impact of therapy on the HIV intact proviral reservoir
1 Year
Other Outcomes (11)
Complete Response(CR) and Complete Response + Partial Response(PR) rates
100 Days
Overall survival
6 months and 1 year
Time to hematopoietic recovery
1 Year
- +8 more other outcomes
Study Arms (1)
HST-NEETs
OTHERHIV+ Participants that were treated with autologous hematopoietic stem cell transplant.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- Karnofsky performance score less than 70%.
- Participant is known to have an HIV subtype other than B.
- Participant has documented raltegravir or protease inhibitor resistance.
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
- Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement).
- Participant has active CNS involvement.
- Participants with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent greater than or equal to 5 years previously will be allowed. Cancer treated with curative intent less than 5 years BMT CLINICAL TRIALS NETWORK HIV T-Cell - Protocol 1903 Version 1.0 Dated February 24, 2021 2-4 Confidential previously may be eligible must be reviewed and approved by the Protocol Officer or Chairs.
- Female participants that are pregnant as per institutional definition or breastfeeding.
- Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant.
- Prior autologous or allogeneic HCT, or prior therapy with chimeric antigen receptor (CAR) T-cells.
- Participants with evidence of MDS/AML or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination. Pathology report documentation need not be submitted.
- Steroids greater than 0.5 mg/kg/day prednisone equivalents.
- Bone marrow involvement by lymphoma at time of workup. Prior history of bone marrow involvement is allowed if cleared prior to ASCT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catherine Bollardlead
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
- Children's National Research Institutecollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
Study Sites (11)
City of Hope National Medical Center
Duarte, California, 91010, United States
Georgetown
Washington D.C., District of Columbia, 20057, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northside
Atlanta, Georgia, 30342, United States
University of Illinois
Chicago, Illinois, 60612, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering (MSKCC)
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MD Anderson
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steve Devine, MD, MS
National Marrow Donor Program
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
July 14, 2021
First Posted
July 23, 2021
Study Start
October 25, 2021
Primary Completion
November 24, 2025
Study Completion
January 5, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Within 6 months of official study closure at participating sites
- Access Criteria
- Available to public
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).