RECRUITING

SynKIR-310 for Relapsed/Refractory B-NHL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-01

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06544265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Andrea Campanile, MS

CONTACT

215-275-4831

andrea.campanile@verismotherapeutics.com

Laura Johnson, PhD

CONTACT

laura.johnson@verismotherapeutics.com

Principal Investigator

Laura A Johnson, PhD

STUDY_CHAIR

Verismo Therapeutics

Study Locations (Sites)

Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

Denver, Colorado, 80218

United States

Collaborators and Investigators

Sponsor: Verismo Therapeutics

Laura A Johnson, PhD, STUDY_CHAIR, Verismo Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2028-12

Study Record Updates