Skip to main content Skip to navigation
We care about your privacy. Read about your rights and how we protect your data. Get Details

COVID-19 Update:Learn where you can get your child vaccinated, as well as other important facts about COVID-19.

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 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.

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 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
- 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
- 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

Contact Information

Principal Investigator:
Boyu Hu, MD - UTAH

Contact: Boyu Hu, MD
Phone: 801-585-3229

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

Full study details on ClinicalTrials.gov