Your session is about to expire
← Back to Search
CAR T-cell Therapy
SynKIR-310 for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Research Sponsored by Verismo Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have refractory or relapsed disease after receiving 2 prior lines of therapies
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
Must not have
Any active uncontrolled systemic fungal, bacterial or viral infection
Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called SynKIR-310 given through a vein to patients with relapsed/refractory B-cell non-Hodgkin's lymphoma to see if it is
Who is the study for?
This trial is for adults over 18 with B-cell Non-Hodgkin's Lymphoma (B-NHL) who have tried at least two treatments or can't/won't get CAR T therapy. They should have relapsed or not responded after treatment, including stem cell transplants done over six months ago. Participants need to be fairly active and healthy overall (ECOG status 0-1).
What is being tested?
The trial tests SynKIR-310, a new drug given through IV once to see if it's safe and works against different types of B-NHL that haven't improved with standard treatments.
What are the potential side effects?
Since this is the first test in humans, specific side effects of SynKIR-310 are unknown but may include typical reactions related to immune therapies such as infusion-related symptoms, fatigue, fever, and potential impacts on blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after two previous treatments.
Select...
I had a stem cell transplant over 6 months ago and do not have graft versus host disease.
Select...
My diagnosis of B-cell Non-Hodgkin Lymphoma is confirmed by tissue analysis.
Select...
I have at least one tumor that can be measured.
Select...
I am fully active or can carry out light work.
Select...
I have either received CAR T therapy before or was unable/unwilling to receive it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any ongoing serious infections.
Select...
I have had treatment for a non-melanoma skin cancer.
Select...
I do not have uncontrolled high blood pressure or recent serious heart issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the safety of SynKIR310
Recommended Phase 2 Dose (RP2D)
Secondary study objectives
Feasibility of SynKIR-310
PD profile of SynKIR-310
PK profile of SynKIR-310
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SynKIR-310Experimental Treatment1 Intervention
Single dose IV administration of SynKIR-310
Find a Location
Who is running the clinical trial?
Verismo TherapeuticsLead Sponsor
3 Previous Clinical Trials
102 Total Patients Enrolled
Laura A Johnson, PhDStudy ChairVerismo Therapeutics