Recurrent OligodendrogliomaPhase 1ADAGiONCT06254326
ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
A Phase 1 study testing TTRNA-DC vaccines with GM-CSF, Autologous Hematopoietic Stem cells (HSCs) and TTRNA-xALT in people with Recurrent Oligodendroglioma and Progressive Oligodendroglioma, run by University of Florida at 1 site in United States.
Trial summary
This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Recurrent Oligodendroglioma, Progressive Oligodendroglioma
- What is being tested?
- TTRNA-DC vaccines with GM-CSF, Autologous Hematopoietic Stem cells (HSCs) and TTRNA-xALT
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 years and above
- Tumor tissue obtained on a screening consent is available.
- Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation.
- Karnofsky Performance Status ≥ 60
- Must be a candidate for surgery/biopsy
- Adequate bone marrow and organ function as defined below:
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- ANC ≥ 1,000/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9 g/dL (can be transfused)
- Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine > 1.5 x IULN
- Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN
- AST (SGOT) and ALT (SGPT) ≤ 3 x IULN
- For females of childbearing potential, negative serum pregnancy test at enrollment
- For women and men of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods
Who cannot join
- Disease progression during treatment with an anti-IDH-1 or anti IDH-2
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
- Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
- Multifocal disease.
- Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
- HIV, Hepatitis B, or Hepatitis C seropositive.
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- Known active infection or immunosuppressive disease.
- Autoimmune disease requiring medical management with immunosuppressant.
- Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.
- Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health Shands Hospital
Gainesville, Florida, 32610
About this study
This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.
Read the detailed description
After screening consent, subjects will undergo standard of care resection or biopsy for confirmatory diagnosis of disease progression and aseptic collection of tumor material for DNA and RNA extraction and sequencing, amplification, and loading of autologous DCs. Following biopsy and confirmatory pathologic diagnosis, eligible patients will be enrolled in treatment.
After surgery, patients will undergo a G-CSF mobilized pheresis to collect PBMCs for DC generation and CD34+ HSCs. Amplified tumor RNA obtained from surgically resected or biopsied specimens will be used to generate total tumor RNA-pulsed DCs (TTRNA-DCs) manufactured while patients initiate salvage chemotherapy regimen after surgery.
Salvage chemotherapy with IDH1/2 inhibitor will initiate 1-2 weeks after G-CSF mobilized leukapheresis for 1-3 cycles after which, treatment cycles will be paused, and the patients will receive 3 priming TTRNA-DCs vaccines every 2 weeks and undergo a non-mobilized leukapheresis to collect vaccine-boosted lymphocytes for ex vivo T cell expansion and generation of additional TTRNA-DC vaccines. Treatment with IDH1/2 inhibitor will resume with monthly TTRNA-DC vaccines for an additional 1-3 cycles until ex vivo expanded T cells are manufactured.
For ACT, patients will undergo non-myeloablative conditioning with cyclophosphamide /fludarabine. The total immunotherapy regimen will consist of up to 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.
The duration of treatment from enrollment to completion of DLT window is anticipated to be 7 to 9 months.
- Being tested
- TTRNA-DC vaccines with GM-CSF, Autologous Hematopoietic Stem cells (HSCs), TTRNA-xALT, Td vaccine
- Keywords
- Immunotherapy, Brain Tumor
- Medical subject headings
- Oligodendroglioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTRNA-DC vaccines with GM-CSFBiological
Participants will receive up to 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
Autologous Hematopoietic Stem cells (HSCs)Biological
Participants will receive a single infusion of autologous CD34+ HSCs
TTRNA-xALTBiological
Participants will receive a single infusion of ex vivo expanded tumor-reactive T cells
Td vaccineDrug
All patients will receive a full Td booster IM vaccine 4-24 hours prior to Vaccine #1 and vaccine site pretreatment with a one-fifth dose of Td intradermally, at the site of planned vaccine, 4-24 hours prior to vaccines #3, #5, #7 and #9.
| Study group | Role | What they receive |
|---|---|---|
| Adoptive Cellular Therapy | Experimental | 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. Receives: Biological: TTRNA-DC vaccines with GM-CSF; Biological: Autologous Hematopoietic Stem cells (HSCs); Biological: TTRNA-xALT; Drug: Td vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of enrolled subject who receive qualified immunotherapy investigational product.
Feasibility will be measured by the number of patients who receive autologous dendritic cells, T cells and hematopoietic stem cells that meet the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7% of enrolled subject must achieve this criterion for feasibility endpoint.
Measured: 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.
Safety will be defined as < 1 DLT out of six enrolled and treated subjects during the defined period of administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion. Investigational treatment related CTCAE V5.0 adverse events 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity will be recorded toward DLT.
Measured: enrollment to completion of DLT window; up to 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start19 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent OligodendrogliomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Oligo Nation, Inc
- Responsible party
- Sponsor
- Investigators
- Duane Mitchell, MD, PhD, Study chair, University of FloridaAshley Ghiaseddin, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254326
- Sponsor's protocol ID
- IRB202301855
- Other IDs
- OCR44817
- Acronym
- ADAGiO
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
- ClinicalTrials.gov ID
- NCT06254326
- Acronym / sponsor ID
- ADAGiO / IRB202301855
- Keywords
- Immunotherapy, Brain Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Oligo Nation, Inc
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.
Detailed description
After screening consent, subjects will undergo standard of care resection or biopsy for confirmatory diagnosis of disease progression and aseptic collection of tumor material for DNA and RNA extraction and sequencing, amplification, and loading of autologous DCs. Following biopsy and confirmatory pathologic diagnosis, eligible patients will be enrolled in treatment.
After surgery, patients will undergo a G-CSF mobilized pheresis to collect PBMCs for DC generation and CD34+ HSCs. Amplified tumor RNA obtained from surgically resected or biopsied specimens will be used to generate total tumor RNA-pulsed DCs (TTRNA-DCs) manufactured while patients initiate salvage chemotherapy regimen after surgery.
Salvage chemotherapy with IDH1/2 inhibitor will initiate 1-2 weeks after G-CSF mobilized leukapheresis for 1-3 cycles after which, treatment cycles will be paused, and the patients will receive 3 priming TTRNA-DCs vaccines every 2 weeks and undergo a non-mobilized leukapheresis to collect vaccine-boosted lymphocytes for ex vivo T cell expansion and generation of additional TTRNA-DC vaccines. Treatment with IDH1/2 inhibitor will resume with monthly TTRNA-DC vaccines for an additional 1-3 cycles until ex vivo expanded T cells are manufactured.
For ACT, patients will undergo non-myeloablative conditioning with cyclophosphamide /fludarabine. The total immunotherapy regimen will consist of up to 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.
The duration of treatment from enrollment to completion of DLT window is anticipated to be 7 to 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adoptive Cellular Therapy | Experimental | Biological: TTRNA-DC vaccines with GM-CSF, Biological: Autologous Hematopoietic Stem cells (HSCs), Biological: TTRNA-xALT, Drug: Td vaccineAll 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, aged 18 years and above
- Tumor tissue obtained on a screening consent is available.
- Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation.
- Karnofsky Performance Status ≥ 60
- Must be a candidate for surgery/biopsy
Key exclusion criteria (18 listed)
- Disease progression during treatment with an anti-IDH-1 or anti IDH-2
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
- Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
- Multifocal disease.
- Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTRNA-DC vaccines with GM-CSFParticipants will receive up to 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 | Biological | Adoptive Cellular Therapy |
| Autologous Hematopoietic Stem cells (HSCs)Participants will receive a single infusion of autologous CD34+ HSCs | Biological | Adoptive Cellular Therapy |
| TTRNA-xALTParticipants will receive a single infusion of ex vivo expanded tumor-reactive T cells | Biological | Adoptive Cellular Therapy |
| Td vaccineAll patients will receive a full Td booster IM vaccine 4-24 hours prior to Vaccine #1 and vaccine site pretreatment with a one-fifth dose of Td intradermally, at the site of planned vaccine, 4-24 hours prior to vaccines #3, #5, #7 and #9. | Drug | Adoptive Cellular Therapy |
Primary outcome
Prevalence of enrolled subject who receive qualified immunotherapy investigational product.
Time frame: enrollment up to 9 months
Feasibility will be measured by the number of patients who receive autologous dendritic cells, T cells and hematopoietic stem cells that meet the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7% of enrolled subject must achieve this criterion for feasibility endpoint.
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.
Time frame: enrollment to completion of DLT window; up to 9 months.
Safety will be defined as < 1 DLT out of six enrolled and treated subjects during the defined period of administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion. Investigational treatment related CTCAE V5.0 adverse events 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity will be recorded toward DLT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duane Mitchell, MD, PhD study chair
University of Florida
Ashley Ghiaseddin, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTRNA-DC vaccines with GM-CSF, Autologous Hematopoietic Stem cells (HSCs) and TTRNA-xALT in people with Recurrent Oligodendroglioma and Progressive Oligodendroglioma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of enrolled subject who receive qualified immunotherapy investigational product. (time frame: enrollment up to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.