SynKIR CAR T Cell Therapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on monitoring long-term risks for individuals who have used SynKIR CAR T cell treatments. These treatments involve altering a person's immune cells to enhance their ability to fight cancer. The study examines two specific treatments: SynKIR-310 and SynKIR-110. Individuals who previously received either of these treatments in a past study may qualify for this trial. The goal is to ensure the safety of these therapies over time. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients over time.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that SynKIR-310, a type of CAR T cell therapy, has been promising in early trials without major safety concerns. In lab tests, often using animals, it performed well and did not cause new safety issues, indicating it was generally well-tolerated.
Similarly, various studies have tested SynKIR-110 for safety. These tests demonstrated a good safety profile, meaning it was generally safe and manageable.
Both treatments continue to undergo careful study to ensure safety for people. Since these are early trials, the main focus remains on checking safety and how the body responds to the treatment. For those considering joining a clinical trial, these findings suggest that both SynKIR-310 and SynKIR-110 have shown a good safety record so far.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about SynKIR-310 and SynKIR-110 because these treatments use a unique approach called Chimeric Antigen Receptor (CAR) T-cell therapy. Unlike traditional cancer treatments like chemotherapy and radiation, which target both healthy and cancerous cells, CAR T-cell therapy involves engineering a patient's own immune cells to specifically target and destroy cancer cells. This targeted approach not only enhances the effectiveness against the cancer cells but also reduces damage to healthy cells, potentially leading to fewer side effects. Additionally, these therapies are tailored to each patient, offering a personalized treatment option that could be more effective for certain individuals.
What evidence suggests that this trial's treatments could be effective?
Research has shown that SynKIR-310, one of the treatments in this trial, may effectively treat certain cancers. In a study with 13 patients, 73.4% experienced a complete response, meaning their cancer was not detectable after treatment. SynKIR-110, another treatment option in this trial, has also shown promise in early studies, significantly reducing tumor growth in mice and completely eliminating some cancer types. Lab tests revealed less toxicity and strong tumor reduction. Both treatments use CAR T-cell therapy, which modifies a person's immune cells to help them fight cancer more effectively.24567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Long-Term Follow-Up
Participants are monitored for long-term safety, delayed adverse events, and persistence of gene-modified T cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SynKIR-110
- SynKIR-310
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants who previously received SynKIR-310 in an interventional trial
Participants who previously received SynKIR-110 in an interventional trial
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verismo Therapeutics
Lead Sponsor
Citations
1.
prnewswire.com
prnewswire.com/news-releases/verismo-therapeutics-presents-promising-preclinical-data-at-sitc-2025-for-synkir-110-in-solid-tumors-302610304.htmlVerismo Therapeutics Presents Promising Preclinical Data ...
SynKIR™-110 exhibited reduced cell exhaustion, lower off-target toxicity, and robust tumor regression in vitro and in vivo compared to ...
321 Preclinical potency assessment of SynKIR-110, a ...
In contrast, high dose SynKIR-110 treated mice showed significant reductions of tumor growth, and complete elimination of malignant neoplasm at ...
Long-Term Follow-Up Safety Study of Subjects Treated ...
The study serves to collect data on delayed adverse events for up to fifteen (15) years following a single infusion of SynKIR-110 administered to advance cancer ...
SynKIR-CAR T cell advanced research (STAR)-101 phase ...
This first-in-human, Phase 1, multicenter, open-label, dose-escalation study evaluates the safety and feasibility of SynKIR-110 in patients with advanced ...
5.
targetedonc.com
targetedonc.com/view/fda-green-lights-fast-track-designation-of-synkir-110-for-mesotheliomaFDA Green Lights Fast Track Designation of SynKIR-110 ...
The investigational new drug, SynKIR-110, has received a fast track designation from the FDA for patients with mesothelioma and is continuing to ...
SynKIR-110 for Mesothelin Expressing Ovarian Cancer ...
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110.
SynKIR-110 for Ovarian Cancer
The safety data for SynKIR-110, also known as Autologous T cells Transduced with Mesothelin KIR-CAR, indicates that it has been evaluated in various studies ...
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