Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04136756
Eligibility Criteria:
Key Inclusion Criteria:
* Patients must have relapsed or refractory MM or NHL with no available therapies that would confer clinical benefit for their primary disease.
* For MM patients, measurable relapsed or refractory MM as defined by the IMWG Criteria (Kumar, 2016) following treatment with at least 3 lines of therapy with no other available treatment that would confer benefit.
* For NHL patients, measurable or detectable disease according to International Myeloma Working Group (IMWG) and the Lugano Classification. Extranodal NHL disease that is measurable by fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging only is allowed.
* Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2.
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
Patient has the following laboratory test results during Screening:
1. Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
2. Platelets ≥ 30,000/µL
3. Hemoglobin ≥ 8g/dL
4. Absolute lymphocytes ≥ 500/µL
5. Leukocytes ≥ 3000/µL
Patients are eligible who also meet all the following criteria in these cohorts of Part 2:
NKTR-255 Monotherapy NHL Group 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.
NKTR-255 with Daratumumab MM Group Only :
* Patients with MM must have had previous exposure to proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
* Patients who previously received daratumumab or other anti-CD38 therapies must have at least 3 months washout.
NKTR-255 with Rituximab Group iNHL Group 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:
* Patients who have an active, known, or suspected autoimmune disease.
* Any treatment-related neurotoxicity or cytokine release syndrome (CRS) prior to enrollment into the study should return to baseline before NKTR-255 treatment.
* Active central nervous system (CNS) involvement with NHL.
* Patients who have been previously treated with prior interleukin-2 or interleukin-15.
* Patients who received daratumumab or other anti-CD38 therapies previously must have 3 months washout.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04136756
Study Brief:
Protocol Section:
NCT04136756