SynKIR-310 for Relapsed/Refractory B-NHL

NCT06544265 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CELESTIAL-301
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

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.

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; 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; Waldenstrom Macroglobulinemia; Waldenstrom Macroglobulinaemia

Outcome Measures

Primary Outcomes (2)

• Evaluate 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). Presence of RCL-VSV-G

  Up to 24 months

• Recommended Phase 2 Dose (RP2D)

  All available data from dose escalation cohorts will be evaluated to determine RP2D

  Up to 24 months

Secondary Outcomes (5)

• Feasibility of SynKIR-310

  Up to 24 months

• Preliminary efficacy : Objective response rate (ORR)

  Up to 24 months

• Preliminary efficacy: Complete response rate (CR)

  Up to 24 months

• Preliminary efficacy: Duration of response (DOR)

  Up to 24 months

• PK profile of SynKIR-310

  Up to 24 months

Study Arms (1)

SynKIR-310

EXPERIMENTAL

Single dose IV administration of SynKIR-310

Biological: SynKIR-310

Interventions

SynKIR-310 BIOLOGICAL

Autologous T Cells transduced with CD19 KIR-CAR

SynKIR-310

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verismo Therapeutics: lead

Study Sites (5)

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

The University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08902, United States

RECRUITING

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Large B-Cell, Diffuse; Pyloric Stenosis, Hypertrophic; Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Laura A Johnson, PhD

  Verismo Therapeutics

  STUDY CHAIR

Central Study Contacts

Physician Connect

CONTACT

267-392-6847; physician.connect@verismotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 9, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)