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 or ritixumab. 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 MM and 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 iNHL patients who previously received rituximab and other therapies to receive NKTR-255 alone and/or in combination with rituximab.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Key Inclusion Criteria:
Patient has the following laboratory test results during Screening:
Patients are eligible who also meet all the following criteria in these cohorts of Part 2:
Cohort A only:
• Patients with NHL who received a commercially approved CD19 CAR-T product and had PD. The first dose of NKTR-255 will be administered within 30 days of the PD.
Cohort B only:
Cohort C only:
• Patients with relapsed or refractory iNHL who previously progressed during or following 1 or more prior systemic rituximab-containing (or another treatment with an anti-CD20 antibody-containing) regimens for lymphoma.
Key Exclusion Criteria:
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
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