Phase
Condition
Inflammation
Lymphoma
Marginal Zone Lymphoma
Treatment
SynKIR-310
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult 18 years of age and older.
Histologically confirmed diagnosis of B-NHL before enrollment.
Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6months prior to enrollment.
If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) thenmust have undergone allo-SCT at least 6 months prior to enrollment and withoutevidence of graft versus host disease.
Measurable disease at time of enrollment: At least one measurable lesion per LuganoResponse Criteria (Cheson et al., 2014).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion
Exclusion Criteria:
Previously treated with any investigational agent within 30 days prior to screening.
Adequately treated non-melanoma skin cancer such as basal cell or squamous cellcarcinoma
Carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and withoutevidence of recurrence for at least 3 years prior to enrollment.
Any other malignancy which has been completely treated and remains in completeremission for ≥ 5 years prior to enrollment. Completely treated prostate cancer withprostate-specific antigen (PSA) level < 1.0 may also be permitted.
Known immunodeficiency disease.
History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascularischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNSinvolvement. For primary CNS disorders that have recovered or are in remission,participants without recurrence within 2 years of planned study enrollment may beincluded.
Uncontrolled hypertension, history of myocarditis or congestive heart failure,unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarctionwithin 6 months prior to study entry.
Any active uncontrolled systemic fungal, bacterial or viral infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver, Colorado 80218
United StatesActive - Recruiting
The University of Kansas Cancer Center
Fairway, Kansas 66205
United StatesActive - Recruiting
Providence Cancer Institute
Portland, Oregon 97213
United StatesActive - Recruiting
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