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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 below
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My condition did not improve after two previous treatments.
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I had a stem cell transplant over 6 months ago and do not have graft versus host disease.
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My diagnosis of B-cell Non-Hodgkin Lymphoma is confirmed by tissue analysis.
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I have at least one tumor that can be measured.
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I am fully active or can carry out light work.
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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:
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I do not have any ongoing serious infections.
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I have had treatment for a non-melanoma skin cancer.
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I do not have uncontrolled high blood pressure or recent serious heart issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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 more

Awards & 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
2 Previous Clinical Trials
142 Total Patients Enrolled
Laura A Johnson, PhDStudy ChairVerismo Therapeutics
~12 spots leftby Sep 2028
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