Status:
ACTIVE_NOT_RECRUITING
Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma
Lead Sponsor:
Catherine Bollard
Conditions:
Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
12-80 years
Phase:
PHASE1
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) in...
Detailed Description
This Phase I, open-label multi-site trial is designed to evaluate the safety of administering rapidly-generated multi-antigen-specific T lymphocytes with the PD1 inhibitor Nivolumab, to relapsed/refra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03843294
Start Date
June 24 2019
End Date
August 1 2026
Last Update
July 3 2025
Active Locations (1)
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1
Utah University School of Medicine/Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112