Status:
RECRUITING
SynKIR-310 for Relapsed/Refractory B-NHL
Lead Sponsor:
Verismo Therapeutics
Conditions:
B Cell Lymphoma
NHL, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed/refrac...
Detailed Description
This is a Phase 1, FIH, multicenter, open-label study of a single infusion of SynKIR-310 in participants with relapsed/refractory B-NHL. Up to 18 participants, regardless of subtypes of B-NHL, who me...
Eligibility Criteria
Inclusion
- 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 6 months prior to enrollment.
- If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease.
- Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion
- Previously treated with any investigational agent within 30 days prior to screening.
- Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma
- Carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
- Any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-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, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
- Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
- Any active uncontrolled systemic fungal, bacterial or viral infection.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06544265
Start Date
November 1 2024
End Date
December 1 2028
Last Update
December 18 2025
Active Locations (5)
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1
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver, Colorado, United States, 80218
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
3
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
4
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08902