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Cancer Vaccine

Adoptive Cellular Therapy for Oligodendroglioma (ADAGiO Trial)

Phase 1

Waitlist Available

Led By Ashley Ghiaseddin, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor tissue obtained on a screening consent is available

Karnofsky Performance Status ≥ 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 9 months

Awards & highlights

ADAGiO Trial Summary

This trial will include 6 patients to assess the safety and feasibility of a new cellular therapy for patients with a specific type of brain tumor that has returned or is getting worse.

Who is the study for?

This trial is for adults with a type of brain tumor called oligodendroglioma that has come back or gotten worse. They must be able to undergo certain medical procedures and treatments.Check my eligibility

What is being tested?

The study tests adoptive cellular therapy, which includes TTRNA-DC vaccines with GM-CSF, autologous hematopoietic stem cells (HSCs), TTRNA-xALT, and the Td vaccine to see if they are safe and workable for these patients.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms, fatigue, fever, chills, weakness, risk of infection due to stem cell use. Specific side effects will depend on individual patient response.

ADAGiO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor tissue is available for screening.

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I can care for myself but may need occasional help.

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I am eligible for surgery or a biopsy.

ADAGiO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 9 months 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 investigational treatment related severe toxicity (Dose-limiting toxicity event) assessed during the period beginning with administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion.

Prevalence of enrolled subject who receive qualified immunotherapy investigational product.

ADAGiO Trial Design

1Treatment groups

Experimental Treatment

Group I: Adoptive Cellular TherapyExperimental Treatment4 Interventions

All participants will receive 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment), a single i.v. infusion of ex vivo expanded tumor-reactive T cells, and a i.v. single infusion of autologous HSCs.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oligo Nation, IncUNKNOWN

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,645 Total Patients Enrolled

Duane Mitchell, MD, PhDStudy ChairUniversity of Florida

4 Previous Clinical Trials

227 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment still open for this ongoing research study?

"Information on clinicaltrials.gov states that this specific research endeavor is not presently enrolling participants. The trial's initial posting was on April 1st, 2024, with the latest update made on February 9th, 2024. Despite its current inactivity in participant recruitment, there are a total of 1016 alternative trials actively seeking eligible individuals to take part."

Answered by AI

What is the safety profile of Adoptive Cellular Therapy in individuals?

"Given that this is a Phase 1 trial with minimal data supporting both safety and effectiveness, Adoptive Cellular Therapy scored a 1 on our safety assessment scale ranging from 1 to 3."

Answered by AI

Are individuals aged 65 and above being actively recruited for participation in this study?

"Individuals aged 18 to 89 years old are eligible for participation based on the specified age requirements in the inclusion criteria."

Answered by AI

What are the specific criteria for individuals to qualify and participate in this trial?

"To be eligible for enrollment in this medical investigation, participants must demonstrate a diagnosis of oligodendroglioma and fall within the age range of 18 to 89 years. The study aims to include approximately 12 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

2024. "ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06254326.

All > Oligodendroglioma