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CAR T-cell Therapy

SynKIR-110 for Ovarian Cancer

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
Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma
Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
Must not have
Pulmonary exclusions
Sarcomatoid/biphasic mesothelioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug to see if it's safe and if it can help people with advanced ovarian, mesothelioma, and cholangiocarcinoma cancer.

Who is the study for?
This trial is for adults over 18 with advanced ovarian cancer, mesothelioma, or cholangiocarcinoma that express a protein called mesothelin. They must have had at least one prior treatment and be in good health otherwise, with no serious heart or lung conditions, other active cancers, immune deficiencies, or autoimmune diseases.
What is being tested?
The trial is testing SynKIR-110 given through the vein to see if it's safe and works against certain cancers. It involves genetically modifying a patient's own T cells to target cancer cells expressing mesothelin.
What are the potential side effects?
Potential side effects may include reactions related to the infusion of modified T cells such as fever, fatigue, and possible immune system responses against normal organs (autoimmune-like effects).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured on scans.
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My cancer has returned after treatment and is one of the specified types.
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I am fully active or can carry out light work.
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My ovarian cancer or mesothelioma has high mesothelin levels, or my cholangiocarcinoma shows some mesothelin presence.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lungs do not have any conditions that would exclude me.
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My condition is sarcomatoid or biphasic mesothelioma.
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I have had cancer affecting my immune cells or received gene-engineered T cell therapy.
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I do not have active hepatitis B, C, or HIV.
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I have a genetic or born-with immune system disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Safety and Feasibility of SynKIR-110
Secondary study objectives
Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 dose

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-110Experimental Treatment1 Intervention
Single dose gravity drip IV administration

Find a Location

Who is running the clinical trial?

Verismo TherapeuticsLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
Laura Johnson, PhDStudy DirectorVerismo Therapeutics
1 Previous Clinical Trials
Mala K Talekar, MBBS,DABPStudy DirectorVerismo Therapeutics

Media Library

Autologous T cells Transduced with Mesothelin KIR-CAR (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05568680 — Phase 1
Mesothelioma Research Study Groups: SynKIR-110
Mesothelioma Clinical Trial 2023: Autologous T cells Transduced with Mesothelin KIR-CAR Highlights & Side Effects. Trial Name: NCT05568680 — Phase 1
Autologous T cells Transduced with Mesothelin KIR-CAR (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05568680 — Phase 1
~27 spots leftby Dec 2027
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