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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Autologous T Cells transduced with CD19 KIR-CAR
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver, Colorado, United States
RECRUITINGWinship Cancer Institute of Emory University
Atlanta, Georgia, United States
RECRUITINGThe University of Kansas Cancer Center
Fairway, Kansas, United States
RECRUITINGRutgers Cancer Institute
New Brunswick, New Jersey, United States
RECRUITINGAbramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGEvaluate the safety of SynKIR310
The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs).
Time frame: Up to 24 months
Recommended Phase 2 Dose (RP2D)
All available data from dose escalation cohorts will be evaluated to determine RP2D
Time frame: Up to 24 months
Feasibility of SynKIR-310
Number of enrolled patients who receive SynKIR-310.
Time frame: Up to 24 months
Preliminary efficacy : Objective response rate (ORR)
Percentage of patients with a complete or partial response determined by Investigator
Time frame: Up to 24 months
Preliminary efficacy: Complete response rate (CR)
Percentage of patients with a Complete Response determined by Investigator
Time frame: Up to 24 months
Preliminary efficacy: Duration of response (DOR)
Time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause, determined by Investigator
Time frame: Up to 24 months
PD profile of SynKIR-310
To evaluate concentration of cytokines in serum over time following SynKIR-310 infusion
Time frame: Up to 24 months
PK profile of SynKIR-310
To evaluate the patients who show CAR T persistence in blood (measured in the blood by quantitative polymerase chain reaction (PCR)) at multiple study time points following SynKIR-310 infusion
Time frame: Up to 24 months
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