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Back|NCT06544265Recruiting
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

Phase
Phase 1
Sponsor
Verismo Therapeutics
Enrollment
18
Timeline
Nov 2024 → Dec 2028
About This Study

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 Criteria

  • 1Adult 18 years of age and older.
  • 2Histologically confirmed diagnosis of B-NHL before enrollment.
  • 3Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
  • 4Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
  • 5If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
  • 6If 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.
  • 7Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014).
  • 8Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

  • 1Previously treated with any investigational agent within 30 days prior to screening.
  • 2Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma
  • 3Carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
  • 4Any 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.
  • 5Known immunodeficiency disease.
  • 6History 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.
  • 7Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
  • 8Any active uncontrolled systemic fungal, bacterial or viral infection.

Locations

5 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Edmund Waller, MD, PhD

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

Denver, Colorado 80218

Recruiting

Michael T. Tees, MD

The University of Kansas Cancer Center

Fairway, Kansas 66205

Recruiting

Joseph McGuirk, DO

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →