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

Completed · Phase 2

Conditions studied: HIV Associated Lymphoma

In brief

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

Key facts

Study ID

NCT04975698

Run by

Catherine Bollard

People needed

12

Starts

2021-10-25

Expected to finish

2026-01-05

Last updated by the study team

2026-06-29

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Georgetown — Washington D.C., District of Columbia, 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
• 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

Full record on ClinicalTrials.gov

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