Last updated on May 2020

NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non Hodgkin Lymphoma & Combined With Daratumumab for Multiple Myeloma

Brief description of study

Patients will receive intravenous NKTR-255 in 21-day treatment cycles. During the Part 1 dose escalation portion of the trial, NKTR-255 will be given as monotherapy. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, approximately 18 Multiple Myeloma (MM) or non-Hodgkin lymphoma (NHL) patients who may have received a chimeric antigen receptor T-cell (CAR-T) product and had progressive disease (PD) will receive NKTR-255 and approximately 18 MM patients who previously received daratumumab or other anti-CD38 therapies will receive NKTR-255 and daratumumab.

Phase 1 study to evaluate safety and tolerability of NKTR-255 along and in combination with daratumumab in subjects with relapsed/refractory NHL and multiple myeloma.

Detailed Study 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 daratumumab. 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.

The NKTR-255 starting dose in Dose Group 1 will be 1.5 g/kg. Patients will receive intravenous (IV) NKTR-255 in 21-day cycles, starting on Cycle 1 Day 1.

Clinical Study Identifier: NCT04136756

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