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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 andfeasibility of administering rapidly-generated Tumor associated antigen specific T cells(TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractorylymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapyfollowing autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk ofrelapse (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

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 ≥ 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
- Relapsed <12 months from diagnosis or <6 months from completion of initial therapy
- Patients with - Patients requiring >1 salvage regimen prior to autologous HSCT
Recipient Procurement (TAA-T Cell Generation) Inclusion Criteria
- Age 12 years to 80 years
- Karnofsky/Lansky score of ≥ 50 (see appendix C).
- Agree to use contraceptive measures during study protocol participation (when age
appropriate)
- Patient or parent/guardian capable of providing informed consent
Recipient Procurement (TAA-T Cell Generation) Exclusion Criteria
- 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 Infusion
- Age 12 years to 80 years
- Patient has received at least 4 doses of Nivolumab
- All toxicities attributed to Nivolumab have resolved Steroids less than 0.5 mg/kg/day
prednisone or equivalent
- Karnofsky/Lansky score of ≥ 50
- Pulse oximetry of > 90% on room air
- Bilirubin ≤ 2.5 mg/dL, AST/ALT ≤ 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 Infusion
- Investigational therapies within the last 28 days
- 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