SynKIR-310 for Relapsed/Refractory B-NHL

Trial Title: SynKIR-310 for Relapsed/Refractory B-NHL

NCT ID: NCT06544265

Condition: 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
HGBL with MYC and BCL2 And/or BCL6 Rearrangements
High-grade B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Large B-cell Lymphoma
T-Cell/Histiocyte Rich Lymphoma
Non-hodgkin Lymphoma,B Cell
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Epstein-Barr Virus Positive DLBCL, Nos
Follicular Lymphoma Grade 3B
DLBCL (Diffuse Large B-Cell Lymphoma) Associated with Chronic Inflammation
High Grade B-Cell Lymphoma, Not Otherwise Specified
Follicular Lymphoma Grade 3
Marginal Zone Splenic Lymphoma
DLBCL

Conditions: Official terms:
Epstein-Barr Virus Infections
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Inflammation

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: SynKIR-310
Description: Autologous T Cells transduced with CD19 KIR-CAR
Arm group label: SynKIR-310

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.

Criteria for 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. - 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 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

Address:
City: Denver
Zip: 80218
Country: United States

Status: Recruiting

Contact:
Last name: Cicelia Veloz

Phone: 720-754-8068
Email: cicelia.veloz@sarahcannon.com

Contact backup:
Last name: Autumn Wagner

Phone: 720-754-8068
Email: autumn.wagner@scri.com

Contact backup:
Last name: Michael T. Tees, MD

Start date: October 2024

Completion date: December 2028

Lead sponsor:
Agency: Verismo Therapeutics
Agency class: Industry

Source: Verismo Therapeutics

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06544265