B7-H3.CD28Z.CART in Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Robbie Majzner
Study ID
NCT07358260
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
9 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • B7-H3.CD28Z.CART — BIOLOGICAL
    Modified autologous T cells administered via Intravenous (IV) infusion
  • Fludarabine — DRUG
    Administered intravenously
  • Cyclophosphamide — DRUG
    Administered intravenously

Study Details

The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped responding to standard treatments (relapsed or refractory) and have been identified with a B7-H3 marker. The names of the treatment interventions used in this study are: * B7-H3.CD28Z.CART / B7-H3 CAR T cells * Fludarabine * Cyclophosphamide

Key Dates

First listed
Jan 22, 2026
Start date
Aug 24, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DOSE ESCALATION B7-H3.CD28Z.CART CELL Therapy
    3+3 dose-escalation to define maximum tolerated dose (MTD) and Phase 2 Recommended Dose (RP2D) of autologous B7-H3.CD28Z.CART cells, followed by 2 expansion cohorts (neuroblastoma; other B7-H3-positive solid tumors) at RP2D. * Screening/Baseline: Consent, eligibility, history, exam, performance status, labs (incl. HIV, hepatitis, pregnancy), ECG, echocardiogram (as indicated), imaging and/or bone marrow, neurologic exam. * Leukapheresis: Autologous T-cell collection for CAR T manufacturing prior to lymphodepletion. * Lymphodepleting chemotherapy (Days -4 to -2): Fludarabine + cyclophosphamide IV. * Day 0: Single IV B7-H3.CD28Z.CART infusion (inpatient), with ≥7 days post-infusion monitoring. * Follow-up: Safety and disease assessments through 24 months, then annual long-term gene-therapy follow-up to 15 years. * Optional second infusion: Allowed ≥60 days and ≤2 years after first, with repeat lymphodepletion and same follow-up.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstititeBostonMassachusetts02115
Natalie B Collins, MD
[email protected]
(617) 632-3027
Natalie B. Collins, MD (PRINCIPAL_INVESTIGATOR)

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Neuroblastoma
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OncologyPediatric oncology
By research site
Dana Farber Cancer Institite· Boston, MA

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