Can immune cells plus a checkpoint drug outsmart lymphoma?
NCT ID NCT03843294
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This early-stage trial is testing whether a combination of tumor-specific immune cells (TAA-T) and the drug nivolumab can safely help people with lymphoma that has returned or not responded to treatment. Participants receive two infusions of TAA-T cells along with nivolumab, which is designed to boost the immune system's ability to fight cancer. The study aims to assess safety and see if the combination can shrink tumors or prevent relapse after a stem cell transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tumor-associated antigen-specific T cells (TAA-T) combined with nivolumab
- What this could lead to
- If safe and effective, this combination could offer a new treatment option for patients with lymphoma that has not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits are uncertain. There is a risk of side effects from the T cells or nivolumab, and the treatment may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Disease Specific Inclusion Criteria 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. HL * 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 Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation): * Age \>12 years * Karnofsky/Lansky score of more than or equal to 50 (see appendix C). * ALC \> 600 * Patients receiving Granulocyte colony-stimulating factor (G-CSF) are recommended a washout period of a minimum of two weeks before procurement * Agree to use contraceptive measures during study protocol participation (when age appropriate) * Patient or parent/guardian capable of providing informed consent Recipient Exclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation): * 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 Recipient Inclusion Criteria for Initial and Subsequent TAA-T Cell Infusions: * 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) * Agree to use contraceptive measures during study protocol participation (when age appropriate) * Patient or parent/guardian capable of providing informed consent Recipient Exclusion Criteria for Initial and Subsequent TAA-T Cell Infusions: * Investigational therapies within 28 days prior to screening for enrollment * Uncontrolled infections * Patient with ≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Utah University School of Medicine/Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas