SynKIR-310 for Relapsed/Refractory B-NHL
18 Years and older, Male and Female
CELESTIAL-301 (primary)
NCI-2025-03031
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/refractory B-NHL.
Objectives
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 meet the eligibility
criteria, will be treated in the study.
2 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and
feasibility of treatment with SynKIR-310. Doses will be escalated across 2 cohorts to
determine a Recommended Phase 2 Dose (RP2D).
Once the RP2D has been determined, a dose expansion group will enroll additional
participants regardless of subtypes of B-NHL at the RP2D to further characterize the
safety, feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL.
Eligibility
- 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
Treatment Sites in Georgia
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