Clinical Trials /

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



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

Related Conditions:
  • AIDS-Related Lymphoma
Recruiting Status:

Not yet recruiting


Phase 2

Trial Eligibility



  • Brief Title: HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs)
  • Official Title: Administration of HIV-specific T Cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue - Auto -RESIST

Clinical Trial IDs

  • SECONDARY ID: 2U10HL069294-11
  • NCT ID: NCT04975698


  • HIV Associated Lymphoma




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 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/m2
      on Day -6, Etoposide 100 mg/m2 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/m2 ) of HST-NEETs between Days +3 to +7 based on the clinical condition
      of the participant (as outlined in Section 2.6). 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.

Trial Arms

HST-NEETsOtherParticipants will receive 2x107 /m2 cells as a single intravenous (IV) infusion. The cells will be cryopreserved ideally at 1x107 T cells per mL.
  • Busulfan

Eligibility Criteria

        Eligible participants are HIV positive and plan to be treated by high dose chemotherapy
        followed by an autologous stem cell transplant (ASCT). Participants are a minimum of 15
        years of age with Karnofsky performance status greater than or equal to 70% that have
        primary refractory or recurrent diffuse large B-cell, immunoblastic, plasmablastic, high
        grade, Burkitt, primary effusion lymphoma, or classical Hodgkin lymphoma. Participants must
        have received 2 or 3 prior treatment regimens, including an induction chemotherapy and 1 or
        2 salvage regimens. Monoclonal antibody therapy and local radiation will not be counted as
        prior therapies. Participants must have chemosensitive disease as demonstrated by complete
        or partial response to induction or most recent salvage chemotherapy. Participants cannot
        have had prior autologous, allogeneic HCT, or CART-cell therapy. Participants must initiate
        conditioning therapy within 3 months of stem cell mobilization or bone marrow harvest.
        Blood cell mobilization or bone marrow harvest will be carried out per institutional
        guidelines. Participants may not have HIV refractory to pharmacologic therapy. Patients
        must not have an uncontrolled infection. Participants must not have received previous
        cellular therapy

        Inclusion Criteria:

          1. Age 15 years old or older at time of enrollment.

          2. Receiving antiretroviral therapies (ART) with HIV viral load below the limit of
             detection by standard commercial assay. A single plasma HIV-1 RNA measurement that is
             ≥ the limit of quantification of the FDA-approved commercial assay but

        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

          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

          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.
Maximum Eligible Age:N/A
Minimum Eligible Age:15 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Time Frame:6 Months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:6 Months and 1 Year
Safety Issue:
Description:Participants are considered a failure for this endpoint if they die or if they relapse/progress or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (greater than 3cm)
Measure:The incidence and severity of acute infusion related toxicities
Time Frame:1 Year
Safety Issue:
Description:Acute infusion related toxicities are defined as toxicities related to the infusion of HST-NEETs that occur within 24 hours of the infusion.
Measure:Impact of therapy on the HIV intact proviral reservoir
Time Frame:1 Year
Safety Issue:
Description:Impact on intact proviral reservoir will be assessed using the IPDA at 4-8 weeks prior to transplant and 12 months following ASCT


Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Catherine Bollard

Last Updated

August 20, 2021