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New treatment option for Recurrent Group 3 Medulloblastoma
Official title Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
ClinicalTrials.gov ID: NCT06514898
What this study is testing
What is TTRNA-DC vaccines with GM-CSF?
TTRNA-DC vaccines with GM-CSF is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent group 3 medulloblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 30
You may be able to join if
- 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...
- Patients must currently be prescribed and approved to receive pembrolizumab therapy (patients who have progressed on anti-PD-1 targeting therapy but...
- Must be a candidate for surgery/biopsy Or tumor tissue obtained clinically, has been previously stored in a qualified biorepository suitable for...
- 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)
- Adequate bone marrow and organ function as defined below:
You likely can't join if
- this study:
- Prior discontinuation of PD-1 inhibitor treatment due to toxicity.
- Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
- Known HIV, Hepatitis B, or Hepatitis C seropositive.
- Known active infection or immunosuppressive disease.
- Known autoimmune disease requiring medical management with immunosuppressant.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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)
- 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)
- 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
- For females of childbearing potential, negative serum pregnancy test at enrollment
- 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. or For males with...
- Signed informed consent by patient and/or legally authorized representative
- this study:
- Prior discontinuation of PD-1 inhibitor treatment due to toxicity.
- Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
- Known HIV, Hepatitis B, or Hepatitis C seropositive.
- Known active infection or immunosuppressive disease.
- Known 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).
- Known 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...
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.