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Cancer Vaccine

Cellular Therapy for Brain Tumors (ADAGiO Trial)

Phase 1

Recruiting

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

Must not have

Corticosteroids equivalent to ≥ 4mg dexamethasone daily

Multifocal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 9 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking a steroid dose equal to or more than 4mg of dexamethasone daily.

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My cancer is present in multiple locations.

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My condition worsened despite treatment targeting IDH-1 or IDH-2.

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My cancer has spread to the brain or beyond.

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I have tested positive for HIV, Hepatitis B, or Hepatitis C.

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I have an active infection or a disease that weakens my immune system.

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I am on medication for an autoimmune disease.

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I do not have severe health issues that would prevent me from safely participating.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met