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ADAGiONCT06254326

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

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 14 versions: 11 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 32 words
  2. Trial status changed: Active, Not Recruiting → Recruiting
    • Site details revised
    v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v11
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Sep 19, 2024
    • Site details revised
    v4
  4. Start date: Jun 2024 to Oct 2024v3
  5. Start date: Apr 2024 to Jun 2024v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Prevalence of enrolled subject who receive qualified immunotherapy investigational product.
Timeframe: enrollment up to 9 months
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.
Timeframe: enrollment to completion of DLT window; up to 9 months.

Arms and interventions

Adoptive Cellular TherapyExperimental

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.

Biologicals: TTRNA-DC vaccines with GM-CSF, Autologous Hematopoietic Stem cells (HSCs), TTRNA-xALT

Drugs: Td vaccine

Sites

1 site in 1 country

  • University of Florida Health Shands HospitalGainesville, Florida, United States