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Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma

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ClinicalTrials.gov Identifier: NCT03843294
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Catherine Bollard, Children's National Research Institute

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) 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.


Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Biological: TAA-T cells Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Utilizing Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor Nivolumab for Relapsed/Refractory Lymphoma
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: Nivolumab with TAA-T cell
Patients will receive doses of Nivolumab at a minimum of 8 weeks prior to first TAA-T cell infusion and additional dose(s) of Nivolumab will be given after 4 weeks following second TAA-T cell infusion starting at week 7 from first infusion of TAA-T.If patient meets eligibility criteria for TAA-T cell infusion, the patient will receive two TAA-T cell infusions given 2 weeks apart
Biological: TAA-T cells
The patient will receive two TAA-T cell infusions given 2 weeks apart. TAA-T cell dose: 2 x 107 cells/m2.per infusion.

Drug: Nivolumab
Nivolumab: For patients <18 years, 3 mg/kg/dose (maximum 240mg/dose) every 2 weeks. For adult patients ≥18 years, a dose of 240mg every 2 weeks or 480mg every 4 weeks




Primary Outcome Measures :
  1. Incidence of Product-Emergent Adverse Events [ Time Frame: 6 weeks from the first TAA-T cell administrations ]
    Number of participants with grades 3-5 infusion-related and grades 4-5 non-hematological adverse events that are not due to the original malignancy, or pre-existing co-morbidities at least 6 weeks of the first dose of TAA-T infusion as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, change from baseline up to week 6.


Secondary Outcome Measures :
  1. Tumor response to combination immunotherapy [ Time Frame: 1 year ]
    Number of patients with tumor associated antigen lymphocytes (TAA-T) with Nivolumab response, change from baseline at year one. Response will be assessed by imaging using the Lugano criteria. Response is defined as any patient who does not progress on this study, including patients with active disease who achieve Complete Metabolic Response (CMR)/Complete Response (CR), Partial Metabolic Response (PMR)/ Partial Response (PR), or No Metabolic Response(NMR)/Stable Disease (SD) by PET/CT.



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <CMR/CR (by PET/CT) prior to autologous HSCT
  • 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 <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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843294


Contacts
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Contact: Hema Dave, MD 202-476-6397 HKDave@childrensnational.org
Contact: Fahmida Hoq, MBBS, MS 202-476-3634 fhoq@childrensnational.org

Locations
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United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Hema Dave, MD    202-476-6397    HKDave@childrensnational.org   
United States, Utah
Utah University School of Medicine/Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Martha Glenn, MD       Martha.Glenn@hci.utah.edu   
Principal Investigator: Martha Glenn, MD         
Sponsors and Collaborators
Catherine Bollard
Investigators
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Principal Investigator: Hema Dave, MD CNMC
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Responsible Party: Catherine Bollard, PI for SUSTAIN, ONCOLOGIST, Hematology/Oncology, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT03843294    
Other Study ID Numbers: SUSTAIN
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents