B7-H3.CD28Z.CART in CNS Neoplasms

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Robbie Majzner
Study ID
NCT07390539
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Atypical Teratoid/Rhabdoid Tumor
  • Brain Tumor
  • Brain Tumor Adult
  • Brain Tumor, Pediatric
  • Brain Tumor, Recurrent
  • Central Nervous System Neoplasms
  • Embryonal Tumor With Multilayered Rosettes
  • Ependymoma
  • Leptomeningeal Disease
  • Medulloblastoma
  • Medulloblastoma Recurrent
  • Medulloblastoma, Adult
  • Medulloblastoma, Childhood
  • Pineoblastoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • B7-H3.CD28Z.CART — BIOLOGICAL
    Autologous CAR T cells targeting B7-H3 (CD276), administered intravenously (into the vein) per protocol.
  • Fludarabine — DRUG
    Lymphodepleting chemotherapy administered intravenously per institutional standards.
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy administered intravenously per institutional standards.

Study Details

The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The names of the study investigational therapies involved in this study are: * Fludarabine (a type of chemotherapy) * Cyclophosphamide (a type of chemotherapy) * B7-H3 CAR T cells (a type of cellular therapy)

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2032

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation for B7-H3.CD28Z.CART in Standard Risk Stratum
    Participants will be enrolled in a staggered, sequential fashion using a modified 3 + 3 dose escalation design, assigning participants to one of three intravenous dose levels to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of IV B7-H3.CD28Z.CART. Dose escalation will occur per dose-limiting toxicity rules. * Baseline visit * Apheresis to obtain T cells * Days -4, -3, -2: predetermined doses of Fludarabine and Cyclophosphamide 1x daily * Day 0: B7-H3 CAR T cell infusion 1x daily * 2 doses of B7-H3 CAR T cell infusion Intracerebroventricular (ICV) Infusion every 28 days until 8 doses total according to clinical response * Follow up every 3 months after last infusion up until 2 years * Long term follow annually for an additional 13 years
  • Experimental: Dose Escalation for B7-H3.CD28Z.CART in High Risk Stratum
    Participants will be enrolled in a staggered, sequential fashion using a modified 3 + 3 dose escalation design, assigning participants to one of three intravenous dose levels to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of IV B7-H3.CD28Z.CART. Dose escalation will occur per dose-limiting toxicity rules. * Baseline visit * Apheresis to obtain T cells * Days -4, -3, -2: predetermined doses of Fludarabine and Cyclophosphamide 1x daily * Day 0: B7-H3 CAR T cell infusion 1x daily * 2 doses of B7-H3 CAR T cell infusion Intracerebroventricular (ICV) Infusion every 28 days until 8 doses total according to clinical response * Follow up every 3 months after last infusion up until 2 years * Long term follow annually for an additional 13 years
  • Experimental: Dose Expansion for B7-H3.CD28Z.CART in Standard Risk Stratum
    Dose expansion will occur per dose-limiting toxicity rules. * Baseline visit * Apheresis to obtain T cells * Days -4, -3, -2: predetermined doses of Fludarabine and Cyclophosphamide 1x daily * Day 0: B7-H3 CAR T cell infusion 1x daily * 2 doses of B7-H3 CAR T cell infusion Intracerebroventricular (ICV) Infusion every 28 days until 8 doses total according to clinical response * Follow up every 3 months after last infusion up until 2 years * Long term follow annually for an additional 13 years
  • Experimental: Dose Expansion for B7-H3.CD28Z.CART in High Risk Stratum
    Dose expansion will occur per dose-limiting toxicity rules. * Baseline visit * Apheresis to obtain T cells * Days -4, -3, -2: predetermined doses of Fludarabine and Cyclophosphamide 1x daily * Day 0: B7-H3 CAR T cell infusion 1x daily * 2 doses of B7-H3 CAR T cell infusion Intracerebroventricular (ICV) Infusion every 28 days until 8 doses total according to clinical response * Follow up every 3 months after last infusion up until 2 years * Long term follow annually for an additional 13 years

Primary Outcome Measure

Manufacturing Success Rate of Autologous B7-H3.CD28Z CAR T Cells [ Time Frame: Participants will receive the CART cell infusion on Day 0. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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