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

Sponsor: Catherine Bollard

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04975698

Patient View

This Phase II trial involves autologous stem cell transplantation followed by HST-NEETs for HIV-associated lymphoma. Participants undergo blood collection for HST-NEETs manufacturing, receive pre-transplant conditioning, and ASCT on Day 0. HST-NEETs are administered as a single IV infusion between Days +3 to +7 post-ASCT, with follow-up for at least one year.

Patient Parameters

Program Overview

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 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.

Eligibility Criteria

Exclusion Criteria

  1. Karnofsky performance score less than 70%.
  2. Participant is known to have an HIV subtype other than B.
  3. Participant has documented raltegravir or protease inhibitor resistance.
  4. 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.
  5. Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement).
  6. Participant has active CNS involvement.
  7. 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.
  8. Female participants that are pregnant as per institutional definition or breastfeeding.
  9. Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant.
  10. Prior autologous or allogeneic HCT, or prior therapy with chimeric antigen receptor (CAR) T-cells.
  11. 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.
  12. Steroids greater than 0.5 mg/kg/day prednisone equivalents.
  13. Bone marrow involvement by lymphoma at time of workup. Prior history of bone marrow involvement is allowed if cleared prior to ASCT.

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