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Spots Global Cancer Trial Database for NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

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Trial Identification

Brief Title: NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

Official Title: A Phase 1, Open-label, Multi-center, Dose Escalation and Dose Expansion Study of NKTR-255 in Relapsed or Refractory Hematological Malignancies

Study ID: NCT04136756

Study Description

Brief Summary: Patients will receive intravenous (IV) NKTR-255 in 21 or 28 day treatment cycles. During the Part 1 dose escalation portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in Part 2. During the Part 2 dose expansion portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.

Detailed Description: NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. This is a Phase 1, open-label, multi-center, dose escalation, dose expansion, safety follow-up, and survival follow-up of NKTR-255 as a single agent and NKTR-255 in combination with DARZALEX FASPRO TM or rituximab. Study treatment is defined as any investigational treatment(s) or marketed product(s), intended to be administered to a study patient according to the study enrollment. Part 1 will enroll relapsed/refractory multiple myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) patients. In Part 2, Cohort A will enroll NHL patients who have progressed on a chimeric antigen receptor T-cell (CAR-T) product, Cohort B will enroll MM patients who previously received daratumumab and other anti-CD38 therapies to receive NKTR-255 alone and/or in combination with daratumumab, and Cohort C will enroll indolent Non-Hodgkin's Lymphoma (iNHL) patients who previously received rituximab and other therapies to receive NKTR-255 alone and/or in combination with rituximab.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Western Regional Medical Center - CTCA, Goodyear, Arizona, United States

City of Hope, Duarte, California, United States

University of California, San Francisco, San Francisco, California, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

University of Michigan, Ann Arbor, Michigan, United States

University of Minnesota, Minneapolis, Minnesota, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

New York Medical College, Valhalla, New York, United States

Duke University Health System, Durham, North Carolina, United States

MD Anderson Cancer Center, Houston, Texas, United States

Virginia Cancer Specialists, Fairfax, Virginia, United States

University of Washington, Seattle, Washington, United States

Contact Details

Name: Study Director

Affiliation: Nektar Therapeutics

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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