SynKIR-310 for Relapsed/Refractory B-NHL

Last updated: April 9, 2025
Sponsor: Verismo Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Inflammation

Lymphoma

Marginal Zone Lymphoma

Treatment

SynKIR-310

Clinical Study ID

NCT06544265
CELESTIAL-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 6months prior to enrollment.

  • If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) thenmust have undergone allo-SCT at least 6 months prior to enrollment and withoutevidence of graft versus host disease.

  • Measurable disease at time of enrollment: At least one measurable lesion per LuganoResponse Criteria (Cheson et al., 2014).

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion

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 cellcarcinoma

  • Carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and withoutevidence of recurrence for at least 3 years prior to enrollment.

  • Any other malignancy which has been completely treated and remains in completeremission for ≥ 5 years prior to enrollment. Completely treated prostate cancer withprostate-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, cerebrovascularischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNSinvolvement. For primary CNS disorders that have recovered or are in remission,participants without recurrence within 2 years of planned study enrollment may beincluded.

  • Uncontrolled hypertension, history of myocarditis or congestive heart failure,unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarctionwithin 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

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: SynKIR-310
Phase: 1
Study Start date:
November 01, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Active - Recruiting

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