← Back to Search

CTO1681 for Preventing Side Effects in Cancer Therapy

Phase 1 & 2
Recruiting
Research Sponsored by CytoAgents, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following start of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug to reduce side effects from CAR T-cell therapy for adults with DLBCL. Participants start taking the drug just before CAR T-cell therapy and continue for 15 days.

Who is the study for?
Adults with DLBCL who are set to receive CD19-directed CAR T-cell therapy and meet specific health criteria, such as adequate organ function and blood counts. They must not have certain heart conditions or uncontrolled bleeding disorders, be on high-dose anticoagulants, or have had recent chemotherapy.
What is being tested?
CTO1681 is being tested in three different doses to see if it can prevent or lessen the severity of cytokine release syndrome (CRS) caused by CAR T-cell therapy in patients with DLBCL. The trial starts with an open-label phase where everyone gets the drug before their cell therapy.
What are the potential side effects?
Potential side effects of CTO1681 aren't specified here but could include reactions related to immune system activation given its role in managing CRS associated with CAR T-cell treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)
Secondary study objectives
CAR T-cell antitumor response
CAR T-cell concentration in blood
Concentration of CTO1681
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: CTO1681 90 μg Total Daily DoseExperimental Treatment1 Intervention
Participants receive 30 μg CTO1681 orally 3 times daily (total daily dose of 90 μg) for 15 days.
Group II: CTO1681 60 μg Total Daily DoseExperimental Treatment1 Intervention
Participants receive 20 μg CTO1681 orally 3 times daily (total daily dose of 60 μg) for 15 days.
Group III: CTO1681 30 μg Total Daily DoseExperimental Treatment1 Intervention
Participants receive 10 μg CTO1681 orally 3 times daily (total daily dose of 30 μg) for 15 days.

Find a Location

Who is running the clinical trial?

CytoAgents, Inc.Lead Sponsor
TFS HealthScienceUNKNOWN
Lee Schacter, MDStudy DirectorTFS HealthScience
~36 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top