RecruitingRecruiting
SynKIR-310 for Relapsed/Refractory B-NHL
NCT06544265 · Verismo Therapeutics
In plain English
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Official title
A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
About this study
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 36 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study.
Up to 4 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 up to 4 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 criteria
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, and expectation to remain off immunosuppressive therapy through duration of trial
* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria:
* Previously treated with any investigational agent within 30 days prior to screening.
* Any previous or concurrent malignancy, with the following exceptions:
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 or adequately treated melanoma skin cancer in-situ; 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.
* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis
* Known immunodeficiency disease , with the exception of hypoglobulinemia
* 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.
Study design
Enrollment target: 36 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-01
Estimated completion: 2028-12
Last updated: 2026-04-14
Interventions
Biological: SynKIR-310
Primary outcomes
- • Evaluate the safety of SynKIR310 (Up to 24 months)
- • Recommended Phase 2 Dose (RP2D) (Up to 24 months)
Sponsor
Verismo Therapeutics · industry
Contacts & investigators
ContactPhysician Connect · contact · physician.connect@verismotherapeutics.com · 267-392-6847
InvestigatorLaura A Johnson, PhD · study_chair, Verismo Therapeutics
All locations (5)
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer InstituteRecruiting
Denver, Colorado, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
The University of Kansas Cancer CenterRecruiting
Fairway, Kansas, United States
Rutgers Cancer InstituteRecruiting
New Brunswick, New Jersey, United States
Abramson Cancer Center of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States