Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Catherine Bollard
Study ID
NCT03843294
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TAA-T cells — BIOLOGICAL
    The patient will receive two TAA-T cell infusions given 2 weeks apart. TAA-T cell dose: 2 x 107 cells/m2.per infusion.
  • Nivolumab — DRUG
    Nivolumab: For patients \<18 years, 3 mg/kg/dose (maximum 240mg/dose) every 2 weeks. For adult patients ≥18 years, a dose of 240mg every 2 weeks or 480mg every 4 weeks

Study Details

This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapy following autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk of relapse (group B). The purpose of this study is to find out if the tumor specific T cells given with Nivolumab are safe and to learn what the side effects are and if the combination can help patients with relapsed lymphomas.

Key Dates

Start date
Jun 24, 2019
Status verified
Jul 2025
Primary completion
May 2, 2023
Completion
Aug 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab with TAA-T cell
    Patients will receive doses of Nivolumab at a minimum of 8 weeks prior to first TAA-T cell infusion and additional dose(s) of Nivolumab will be given after 4 weeks following second TAA-T cell infusion starting at week 7 from first infusion of TAA-T.If patient meets eligibility criteria for TAA-T cell infusion, the patient will receive two TAA-T cell infusions given 2 weeks apart

Primary Outcome Measure

Incidence of Product-Emergent Adverse Events [ Time Frame: 6 weeks from the first TAA-T cell administrations ]

Locations (1)

FacilityCityStateZIPSite coordinators
Utah University School of Medicine/Huntsman Cancer InstituteSalt Lake CityUtah84112-

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By research site
Utah University School of Medicine/Huntsman Cancer Institute· Salt Lake City, UT

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