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  • Cancer Type: Malignant Hematology
  • Study Type: Treatment
  • NCT#: NCT04975698
  • Phase: Phase II
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  • Overview

    Study Title:

    Administration of HIV-specific T Cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue -Auto-RESIST

    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

    Objective:

    The primary objective is to determine 1.) the proportion of participants who can be treated with HIV antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) within 1 week of autologous hematopoietic stem cell transplantation (ASCT) in a cooperative multi-institutional setting and 2.) the efficacy of HST-NEETs in reducing the HIV intact proviral reservoir at 6 months after ASCT. Secondary Objectives: 1. Progression-free survival at 6 months and 1 year post-ASCT; 2. The incidence and severity of acute infusion-related toxicities; 3. The impact of therapy on the HIV intact proviral reservoir at 1 year post-ASCT.

  • Treatments

    Therapies:

    Therapy (NOS)

    Medications:

    Alkeran (Melphalan); Carmustine (); Cytarabine (Cytosine Arabinoside); Melphalan (); etoposide ()

  • Inclusion Criteria

    • Age 15 years old or older at time of enrollment.
    • Receiving antiretroviral therapies (ART) with HIV viral load > Diagnosis of refractory or recurrent diffuse large B-cell lymphoma, composite lymphoma with greater than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma, immunoblastic, plasmablastic, Burkitt or high grade B cell lymphoma or classical Hodgkin lymphoma. Participants with aggressive B-cell lymphoma that is transformed from follicular lymphoma are eligible for the study, pending fulfillment of other criteria.
    • Two or three prior regimens of chemotherapy over the entire course of their disease treatment (induction chemotherapy and salvage chemotherapies). Monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies
    • All participants must have chemosensitive disease as demonstrated by at least a partial response (as defined by the criteria in Chapter 3) to induction or salvage therapy. Absolute Lymphocyte Count (ALC) greater than or equal to 1000/┬ÁL.
    • Participants with adequate organ function as defined by protocol
    • Plan to treat participant with high dose chemotherapy and autologous hematopoietic stem cell transplantation (ASCT).
    • Voluntary written consent or assent obtained prior to enrollment on study with the understanding that consent or assent may be withdrawn by the participant at any time without prejudice to future medical care.
  • Exclusion Criteria

    • 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.

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