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

Active:	No
Cancer Type:	Multiple Myeloma Non-Hodgkin Lymphoma	NCT ID:	NCT04136756
Trial Phases:	Phase I	Protocol IDs:	18-255-02 (primary) NCI-2019-07642
Eligibility:	18 - 80 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Nektar
NCI Full Details:	http://clinicaltrials.gov/show/NCT04136756

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.

Objectives

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.

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