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

NCT03843294 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SUSTAIN
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Product-Emergent Adverse Events

  Number of participants with grades 3-5 infusion-related and grades 4-5 non-hematological adverse events that are not due to the original malignancy, or pre-existing co-morbidities at least 6 weeks of the first dose of TAA-T infusion as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, change from baseline up to week 6.

  6 weeks from the first TAA-T cell administrations

Secondary Outcomes (1)

• Tumor response to combination immunotherapy

  1 year

Study Arms (1)

Nivolumab with TAA-T cell

EXPERIMENTAL

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

Biological: TAA-T cells; Drug: Nivolumab

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 with TAA-T cell

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

Nivolumab with TAA-T cell

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B cell Lymphoma (DLBCL) DLBCL
• Patients who have failed at least 2 lines of prior therapy with a failed attempt at both an autologous stem cell transplant and chimeric antigen receptor T cell therapy.
• Patients who are deemed autologous stem cell transplant ineligible and have failed only one line of prior therapy.
• Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy unless the treatment was anti-CD20 antibody monotherapy.
• Rel/ref HL failing more than or equal to 1 salvage regimens, including prior Brentuximab Vedotin (BV)
• Rel/ref after autologous HSCT
• Group B (consolidation after auto-HSCT for patients at high risk for relapse) DLBCL
• Patients with \< CMR/CR (by PET/CT) with initial treatment regimen
• Patients with relapse \<12 months from diagnosis or \<6 months from completion of initial therapy
• Patients with \<CMR/CR (by PET/CT) prior to autologous HSCT
• Patients requiring \>1 salvage regimen prior to autologous HSCT HL
• Patients with relapse \<12 months from diagnosis or \<6 months from completion of initial therapy
• Patients with \<CMR/CR (by PET/CT) prior to autologous HSCT
• Patients requiring \>1 salvage regimen prior to autologous HSCT
• Age \>12 years

You may not qualify if:

• Prior allogeneic BMT
• Prior solid organ transplant
• Patient who has received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment
• Patient with uncontrolled infections
• Patient with active HIV
• Pregnancy or lactating
• Failure to meet institutional guidelines for treatment with Nivolumab
• Age \>12 years
• Patient has received at least 8 weeks of Nivolumab
• Patients with Grade 1 toxicities attributed to Nivolumab will be eligible at the discretion of the PI. Toxicities include but not limited to: laboratory abnormalities in thyroid function tests suggestive of hypothyroidism, thyroiditis or thyroid dysfunction adequately managed with thyroid hormone replacement, or abnormalities in amylase, lipase
• Steroids less than 0.5 mg/kg/day prednisone or equivalent
• Karnofsky/Lansky score of more than or equal to 50
• Pulse oximetry of \> 90% on room air
• Bilirubin less than or equal to 2.5 mg/dL, AST/ALT less than or equal to 5x upper limit of normal, serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher)
• Absolute neutrophil count \> 250/µL (may be supported with GCSF)

Sponsors & Collaborators

• Catherine Bollard: lead

Study Sites (1)

Utah University School of Medicine/Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Dave H, Terpilowski M, Mai M, Toner K, Grant M, Stanojevic M, Lazarski C, Shibli A, Bien SA, Maglo P, Hoq F, Schore R, Glenn M, Hu B, Hanley PJ, Ambinder R, Bollard CM. Tumor-associated antigen-specific T cells with nivolumab are safe and persist in vivo in relapsed/refractory Hodgkin lymphoma. Blood Adv. 2022 Jan 25;6(2):473-485. doi: 10.1182/bloodadvances.2021005343.

  PMID: 34495306 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large B-Cell, Diffuse

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Boyu Hu, MD

  UTAH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director - Center for Cancer and Immunology Research

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: February 18, 2019
• Study Start: June 24, 2019
• Primary Completion: May 2, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1)