QUILT 3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell 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: NCT04052061|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma Large-cell Lymphoma Lymphoma, B-Cell Lymphoma||Biological: CD19 t-haNK||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Phase 1 Study of CD19 t-haNK In Subjects With Diffuse Large B-Cell Lymphoma Who Have Received 2 Or More Lines of Therapy And Are Ineligible For Transplant|
|Estimated Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||September 18, 2023|
|Estimated Study Completion Date :||December 18, 2023|
Experimental: CD19 t-haNK
CD19 t-haNK will be administered to patients with Diffuse Large B-Cell Lymphoma who have received 2 or more lines of therapy and are ineligible for transplant.
Biological: CD19 t-haNK
CD19 t-haNK Suspension for Infusion
- MTD or HTD and RP2D. [ Time Frame: 1 year ]Maximum tolerated dose or highest tested dose and recommended phase 2 dose.
- Incidence of DLTs and treatment-emergent adverse events [ Time Frame: 1 year ]Incidence of DLTs and treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- Clinically significant changes [ Time Frame: 1 year ]Clinically significant changes in safety laboratory tests, physical examinations, electrocardiograms (ECGs), and vital signs, as determined by the physician and/or lab ranges.
- Objective Response Rate (ORR) [ Time Frame: 1 year ]ORR in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified RECIST guidelines for immunotherapy trials (iRECIST).
- Progression-free Survival (PFS) [ Time Frame: 1 year ]Progression-free Survival (PFS) by RECIST Version 1.1 and iRECIST.
- Overall Survival (OS) [ Time Frame: 1 year ]OS will be evaluated using Kaplan-Meier methods.
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): NCT04052061
|Contact: Laura Zambanini, PMP||310-882-0912||Laura.Zambanini@NantKwest.com|
|United States, California|
|Chan Soon-Shiong Institute for Medicine|
|El Segundo, California, United States, 90245|