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New treatment option for Medulloblastoma, Childhood
Official title Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
ClinicalTrials.gov ID: NCT06193759
What this study is testing
What is Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA)?
Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for medulloblastoma, childhood.
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 an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- RECIPIENT SCREENING 1. Diagnosis (select one group):
- Group A: New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical...
- Group B: Radiographic evidence consistent with recurrent ependymoma, with planned or recent re-resection.
- Age:
- Group A: \<5 years of age at enrollment
You likely can't join if
- RECIPIENT SCREENING EXCLUSION CRITERIA 1\. Patients with uncontrolled infections. 2. Patients with known HIV infection. 3. Group A patients with...
- Patients with progressive disease based on most recent evaluation (for subsequent infusions). a. Patients with progressive disease based on most...
- Patients with uncontrolled infections.
- Patients who have overly bulky tumors on imaging are ineligible. These include the following: i. Tumor with any evidence of herniation or significant...
- Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.
- Patients receiving steroids (e.g., dexamethasone) at a dose of \>0.05 mg/kg/day.
See the full eligibility criteria
- RECIPIENT SCREENING 1. Diagnosis (select one group):
- Group A: New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical teratoid/rhabdoid tumor, and embryonal tumor, not otherwise specified (NOS).
- Group B: Radiographic evidence consistent with recurrent ependymoma, with planned or recent re-resection.
- Age:
- Group A: \<5 years of age at enrollment
- Group B: \>1 year and \<30 years of age at enrollment
- Tissue: o Group A: Availability of sufficient fresh or frozen tumor tissue (approximately 50 mg). o Group B: Expectation of sufficient fresh or frozen tumor tissue, in the opinion of study PI or sub-I (based upon...
- Non-pregnant:
- Group A: N/A
- Group B: For female of childbearing potential, must have negative pregnancy test. Common to both groups:
- Karnofsky or Lansky score of ≥60%.
- Adequate organ function, defined below: i. ANC ≥750/µL. ii. Absolute lymphocyte count (ALC) \>500/μL. iii. Platelets ≥75K. iv. Bilirubin ≤3xULN. v. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \...
- The patient (if ≥18 years old), or the patient's parent(s)/legal guardian(s) (if the patient is a minor), is capable of providing informed consent.
- Patient deemed to be of sufficient size to undergo MNC apheresis for TSA-T generation (Groups A and B) and PBSC rescue (Group A only).
- Patient is a surgical candidate for placement of a Rickham reservoir in the opinion of study PI or medically licensed sub-I. RECIPIENT FOR PROCUREMENT 1\. Karnofsky or Lansky score of ≥60%. 2. Adequate organ function...
- Group A: N/A
- Group B: For female of childbearing potential (if applicable), must have negative pregnancy test. RECIPIENT FOR INITIAL TSA-T ADMINISTRATION AND FOR ADDITIONAL INFUSIONS
- Applicable to TSA-T infusion #1 only: Group B participants must have histopathologic confirmation of recurrent ependymoma.
- Karnofsky or Lansky score of ≥60%.
- Adequate organ function, defined as below: i. Bilirubin ≤3x ULN. ii. AST and ALT ≤5x ULN. iii. Serum creatinine ≤1.0mg/dL or 1.5x ULN for age (whichever is higher). iv. Pulse oximetry \>90% on room air.
- Applicable to TSA-T Infusion #1 only: Adequate count recovery, as described below, from prior therapies: i. Absolute Neutrophil Count (ANC) \>1000/μL ii. Absolute Lymphocyte Count (ALC) \>500/μL
- Patients must have received their last dose of: a. Myelosuppressive chemotherapy (if applicable) ≥14 days prior to TSA-T infusion b. Focal radiation (if applicable) ≥14 days prior to TSA-T infusion c. Craniospinal...
- Patients must have recovered from all acute effects of prior surgical intervention/s.
- Group B female of childbearing potential or male capable of fathering a child (if applicable): Agree to use contraceptive measures during TSA-T treatment participation through 6 months following last administration of...
- Group B female of childbearing potential (if applicable), must have negative pregnancy test.
- Neurologic status: Patient must have a stable neurologic exam for 2 weeks, on a stable or decreasing dose of steroids, prior to administration of the first dose of TSA-T cells, and stability for 1 week prior to all...
- Presence of a Rickham reservoir and catheter for intracerebroventricular administration of TSA-T therapy, placed \>7 days prior to TSA-T infusion.
- For patients with programmable VP shunts: Able to tolerate the shunt being closed for at least 4 hours, in the opinion of study PI or medically licensed sub-I.
- RECIPIENT SCREENING EXCLUSION CRITERIA 1\. Patients with uncontrolled infections. 2. Patients with known HIV infection. 3. Group A patients with medulloblastoma of the SHH subtype. RECIPIENT EXCLUSION CRITERIA FOR...
- Patients with progressive disease based on most recent evaluation (for subsequent infusions). a. Patients with progressive disease based on most recent evaluation may receive initial TSA-T infusion but would be...
- Patients with uncontrolled infections.
- Patients who have overly bulky tumors on imaging are ineligible. These include the following: i. Tumor with any evidence of herniation or significant midline shift. ii. Tumor with a significant brainstem component. iii...
- Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.
- Patients receiving steroids (e.g., dexamethasone) at a dose of \>0.05 mg/kg/day.
- Patients who have non-programmable VP shunts.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
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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.