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NCT06544265 | RECRUITING | B Cell Lymphoma

SynKIR-310 for Relapsed/Refractory B-NHL
Sponsor:

Verismo Therapeutics

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.

Condition or disease

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

Intervention/treatment

SynKIR-310

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 18 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-11-01
Estimated Primary Completion Date : 2028-09
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
SynKIR-310 for Relapsed/Refractory B-NHL

Location Details

NCT06544265

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How to Participate

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Locations

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Kansas

The University of Kansas Cancer Center

Fairway, Kansas, United States, 66205