SynKIR-310 for Relapsed/Refractory B-NHL

Phase 1

Recruiting

• Conditions: B Cell Lymphoma; NHL, Adult; Mantle Cell Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma; Aggressive B-Cell Non-Hodgkin Lymphoma; Indolent B-Cell Non-Hodgkin Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma
• Interventions: Biological: SynKIR-310

• Registration Number: NCT06544265
• Lead Sponsor: Verismo Therapeutics

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/refractory B-NHL.

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 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 Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2028-09
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 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

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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 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SynKIR-310	SynKIR-310	Single dose IV administration of SynKIR-310

Primary Outcome Measures

Name	Time	Method
Evaluate the safety of SynKIR310	Up to 24 months	The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs).
Recommended Phase 2 Dose (RP2D)	Up to 24 months	All available data from dose escalation cohorts will be evaluated to determine RP2D

Secondary Outcome Measures

Name	Time	Method
Feasibility of SynKIR-310	Up to 24 months	Number of enrolled patients who receive SynKIR-310.
Preliminary efficacy: Duration of response (DOR)	Up to 24 months	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
PK profile of SynKIR-310	Up to 24 months	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
Preliminary efficacy : Objective response rate (ORR)	Up to 24 months	Percentage of patients with a complete or partial response determined by Investigator
Preliminary efficacy: Complete response rate (CR)	Up to 24 months	Percentage of patients with a Complete Response determined by Investigator
PD profile of SynKIR-310	Up to 24 months	To evaluate concentration of cytokines in serum over time following SynKIR-310 infusion

Trial Locations

Locations (1)

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute; 🇺🇸 Denver, Colorado, United States