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The Children's National Research Institute

Phase I Study Utilizing Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor Nivolumab for Relapsed/Refractory Lymphoma

Trial Number: NCT03843294

This is a Phase I, open-label multi-site trial designed to evaluate the safety ofadministering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with theProgrammed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref)patients with measurable disease (group A) or as adjunctive therapy following autologoushematopoeitic 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 Nivolumabare safe and to learn what the side effects are and if the combination can help patients withrelapsed lymphomas.

Eligibility

Ages Eligible for Study: 12 Years to 80 Years
Genders Eligible for Study: All
Accepts Healthy Volunteers: No
Phase: Phase 1
Expected Completion Date: 11/30/2023

Criteria

Disease Specific Inclusion Criteria
Group A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and
Diffuse Large B cell Lymphoma (DLBCL) DLBCL
- Patients with Primary Treatment Failure (PTF) and one or more Ultra-high risk (UHR)
features, no prior salvage treatment required. Please refer to Appendix A for
definitions of PTF and UHR
- Rel/ref DLBCL failing 1st salvage treatment (Progressive disease (PD)/ Stable Disease
(SD)/Partial Response (PR))
- Rel/ref DLBCL without acceptable treatment options in the opinion of the treating
physician 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 - Patients requiring >1 salvage regimen prior to autologous HSCT HL
- Patients not eligible for post auto-HSCT consolidation with Brentuximab AND
- Patients with relapse <12 months from diagnosis or <6 months from completion of
initial therapy
- Patients with - Patients requiring >1 salvage regimen prior to autologous HSCT
Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell
Generation):
- Age 12 years to 80 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 to 80 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

Contact Information

Principal Investigator:
Hema Dave, MD - CNMC

Contact: Fahmida Hoq, MBBS, MS
Phone: (202) 476-3634

Contact: Hema Dave, MD
Phone: (202) 476-6397

Full study details on ClinicalTrials.gov