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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of enrollment through date of last patient visit, up to 36 months.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of enrollment through date of last patient visit, up to 36 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of enrollment through date of last patient visit, up to 36 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and feasibility of SynKIR-110
Secondary outcome measures
Define the MTD or MFD of SynKIR-110
Trial Design
1Treatment groups
Experimental Treatment
Group I: SynKIR-110Experimental Treatment1 Intervention
Single dose gravity drip IV administration
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Who is running the clinical trial?
Verismo TherapeuticsLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Mala K Talekar, MBBS,DABPStudy DirectorVerismo Therapeutics
Laura Johnson, PhDStudy DirectorVerismo Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active cancer except for mesothelioma, cholangiocarcinoma, or ovarian cancer, or any cancer I had has been cured for over 5 years.I am fully active or can carry out light work.My organs and bone marrow are functioning well.My ovarian cancer or mesothelioma has high mesothelin levels, or my cholangiocarcinoma shows some mesothelin presence.I have at least one tumor that can be measured on scans.My cancer has returned after treatment and is one of the specified types.My lungs do not have any conditions that would exclude me.I am 18 years old or older.My condition is sarcomatoid or biphasic mesothelioma.I have had cancer affecting my immune cells or received gene-engineered T cell therapy.I do not have active hepatitis B, C, or HIV.I have a genetic or born-with immune system disorder.Your blood clotting test results are normal.You currently have an autoimmune disease that is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: SynKIR-110
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants currently being sought after for this clinical trial?
"The clinical trial is actively searching for patients, as indicated on the clinicaltrials.gov website. It was first posted on March 30th 2023 and most recently edited April 3rd of the same year."
Answered by AI
How many participants are currently enrolled in this trial?
"Affirmative. Clinicaltrials.gov corroborates that this clinical trial, which had its inception on March 30th 2023, is searching for volunteers now. 42 individuals need to be enrolled from a single medical centre."
Answered by AI
Has SynKIR-110 received federal sanctioning to be utilized?
"Owing to its Phase 1 clinical trial designation, there is limited data presented on SynKIR-110's safety and effectiveness. Our team at Power has thus assigned it a score of 1."
Answered by AI
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