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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following start of treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Secondary outcome measures

CAR T-cell antitumor response

CAR T-cell concentration in blood

Concentration of CTO1681

+5 more

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

CytoAgents, Inc.Lead Sponsor

TFS HealthScienceUNKNOWN

Peter J Larson, MDStudy DirectorTFS HealthScience

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are volunteers for this research project?

"Affirmative, the information found on clinicaltrials.gov evidences that this medical trial is presently in search of individuals to participate. This research was initially posted on September 1st 2023 and most recently amended 13 days later; 54 subjects are being recruited from a single site."

Answered by AI

Is there still an opportunity to enroll in this investigation?

"Affirmative, clinicaltrials.gov reveals that this trial is actively looking for participants. It was originally posted on September 1st 2023 and its details were last updated on the 13th of same month. 54 individuals need to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy

2023. "Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905328.