Adoptive T Cell Therapy and Vaccines for Medulloblastoma

(MATCHPOINT Trial)

Overseen By Marcia Hodik, RN

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: HIV, Hepatitis, Autoimmune, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 3-6 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study in a small number of children and young adults with relapsed/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.

Research Team

Duane Mitchell, MD, PhD

Principal Investigator

University of Florida

John Ligon, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for children and young adults aged 4-30 with a specific type of brain cancer called Group 3 or 4 medulloblastoma that has come back after treatment. They must be able to undergo surgery, have a certain level of physical function, and their major organs need to work well. Those with genetic conditions increasing cancer risk from radiation can join at first recurrence.

Inclusion Criteria

My hemoglobin level is at least 9 g/dL.

I can care for myself but may not be able to do active work or play.

My white blood cell count is at least 1,000 without support.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Initial Treatment Preparation

Participants undergo tumor resection or biopsy, collection of PBMCs for DC generation, and initiation of salvage chemotherapy

4-6 weeks

Multiple visits (in-person) for surgery and chemotherapy initiation

Treatment

Participants receive TTRNA-DC vaccines, undergo leukapheresis for T cell expansion, and continue with salvage chemotherapy

3-6 months

Bi-weekly and monthly visits for vaccines and chemotherapy

Adoptive Cellular Therapy (ACT)

Participants receive non-myeloablative conditioning, infusion of expanded lymphocytes, HSCs, and PD-1 blockade

2 weeks

In-person visits for conditioning and infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 12 months

Regular follow-up visits

Treatment Details

Interventions

• Pembrolizumab
• TTRNA-DC vaccines
• TTRNA-xALT

Trial Overview The study tests a combination therapy in patients with relapsed medulloblastoma: adoptive T cell therapy, dendritic cell vaccines mixed with GM-CSF, hematopoietic stem cells transplant, and Pembrolizumab (an immune checkpoint inhibitor). It's designed to see if this approach is feasible and safe.

Participant Groups

Group I: Adoptive Cellular Therapy (ACT) + PD-1 blockade with pembrolizumab Experimental Treatment 5 Interventions

ACT + PD-1 blockade consists of the intravenous delivery of ex vivo expanded tumor-reactive lymphocytes and autologous hematopoietic stem cells (HSCs) with concomitant tumor RNA-pulsed DC vaccines followed by intravenous delivery of PD-1 blocking antibodies.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+