Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03843294|
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : August 13, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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.
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
|Contact: Hema Dave, MD||202-476-6397||HKDave@childrensnational.org|
|Contact: Fahmida Hoq, MBBS, MSemail@example.com|
|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|
|Principal Investigator:||Hema Dave, MD||CNMC|