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NCT06514898

Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma

Recruiting
PHASE1Ages 4–30InterventionalTreatment
University of Florida
~12 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:TTRNA-DC vaccines with GM-CSFTTRNA-xALTTd vaccineautologous HSCsPembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with immunotherapy-related dose-limiting toxicities after treatment with TTRNA-DCs, TTRNA-xALT and HSCs plus PD1 blockade
Measured over enrollment to completion of DLT window; up to 12 months
+1 more outcome measured

Conditions

Recurrent Group 3 Medulloblastoma
Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma

Explore related trials

MedulloblastomaNF1 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Duane Mitchell, MD, PhD · STUDY_CHAIR · University of Florida
  • John Ligon, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Marcia Hodik, RN
[email protected]
352-273-6971
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Eligibility criteria

Inclusion

ANC ≥ 1,000/mcL (unsupported)
Platelets ≥ 100,000/mcL (unsupported for at least 3 days)
Hemoglobin ≥ 9 g/dL (may be supported)
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 for age OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN for age
AST (SGOT) and ALT (SGPT) ≤ 3 x IULN for age
Cardiac shortening fraction ≥27% or LVEF ≥50% by echocardiogram
Adequate pulmonary function defined as baseline pulse oximetry of ≥92% on room air 6. For females of childbearing potential, negative serum pregnancy test at enrollment 7. For women of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.

Exclusion

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.

What this trial measures

  • Number of participants with immunotherapy-related dose-limiting toxicities after treatment with TTRNA-DCs, TTRNA-xALT and HSCs plus PD1 blockadeenrollment to completion of DLT window; up to 12 months

    Number of subjects with immunotherapy-related dose-limiting toxicities including 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. For the purposes of evaluating the safety of ACT combined with PD-1 blockade, dose limiting toxicities will be assessed during the period beginning with administration of ex vivo expanded tumor-reactive (TTRNA- xALT) through 2 weeks post TTRNA -DC vaccine #9. Safety will be defined as \< 1 DLT out of six enrolled and treated subjects.

  • Number of enrolled participants who receive qualified immunotherapy products out of the total number of participants enrolled.enrollment up to 12 months

    Feasibility will be defined as capacity to enroll, manufacture, and administer qualified immunotherapy products (TTRNA-DCs, TTRNA-xALT and HSCs) to at least 66.7% of enrolled subjects.