RecruitingRecurrent Group 3 MedulloblastomaRecurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
Eligible age
4–30 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This is a pilot study in a small number of children and young adults with suspected recurrent/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.
Sponsor: University of Florida
You may qualify if…
- ✓ 1. Children and young adults ages 4-30 years with suspected recurrence/progression of Group 3 or 4 (non-SHH/non-WNT) MB since completion of definitive focal +/- craniospinal irradiation who are a candidate for surgical resection or biopsy. Of the 6 evaluable subjects, a minimum of 3 slots must be reserved for patients with confirmed Group 4 MB. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence/progression.
- ✓ 2. Patients must currently be prescribed and approved to receive pembrolizumab therapy (patients who have progressed on anti-PD-1 targeting therapy but are otherwise eligible may be enrolled to receive combination with immunotherapy. Patients who have been previously treated with anti-PD-1 targeting therapy alone or in combination with other agents and discontinued for reasons other than toxicity may be enrolled).
- ✓ 3. Must be a candidate for surgery/biopsy Or tumor tissue obtained clinically, has been previously stored in a qualified biorepository suitable for tumor RNA extraction and amplification and sample is made available to the PI.
- ✓ 4. Karnofsky or Lansky Performance Status (KPS) ≥ 60% (KPS for \> 16 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for \< 16 years of age)
- ✓ 5. Adequate bone marrow and organ function as defined below:
- ✓ ANC ≥ 1,000/mcL (unsupported)
- ✓ Platelets ≥ 100,000/mcL (unsupported for at least 3 days)
- ✓ Hemoglobin ≥ 9 g/dL (may be supported)
You may not qualify if…
- ✕ this study:
- ✕ 1. Prior discontinuation of PD-1 inhibitor treatment due to toxicity.
- ✕ 2. Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
- ✕ 3. Known HIV, Hepatitis B, or Hepatitis C seropositive.
- ✕ 4. Known active infection or immunosuppressive disease.
- ✕ 5. Known autoimmune disease requiring medical management with immunosuppressant.
- ✕ 6. Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.
- ✕ 7. Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).
Where it's recruiting
Florida
Gainesville
Source: ClinicalTrials.gov · NCT06514898 · last updated 2026-06-10