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NCT05474378

B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from Stanford University

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Record History

All 11 versions: 10 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Final enrollment: 18 participants (planned 39)
    • Primary and study completion dates: Feb 2027 to Mar 2027
    • Site details revised
  2. Eligibility criteria expanded, about 39 words
    • Primary and study completion pushed from Aug 2026 to Feb 2027
    • Secondary endpoints: details revised at 1 of 5 entries
  3. Site contact updatedv9
  4. Eligibility criteria expanded, about 11 wordsv8
  5. Lead sponsor: Crystal Mackall, MD to Stanford University
    • Primary and study completion dates: Aug 2025 to Aug 2026
    • Collaborators: 1 to 2
    v7
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 12 to 39
    • Site details revised
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 39 to confirmed 12
    • Site details revised
    v5
  3. Site contact updated
    • Collaborators expanded, about 6 words
    v4
  4. Site contact updatedv3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range
Timeframe: 5 years
Maximum Tolerated Dose (MTD) or Recommended phase 2 dose (RP2D)
Timeframe: 5 years

Secondary (5)

Cumulative Safety of B7-H3CART
Immunotherapy Response Assessment in Neuro-oncology (iRANO) in subjects with recurrent IDH wild-type GBM
Time to progression (TTP)
Median overall survival (OS)
Percentage of subjects able to receive at least three (3) doses of B7-H3CART

Arms and interventions

Dose escalationExperimental

All subjects will be assigned to a dose level. Does escalation will proceed sequentially via a standard 3+3 dose escalation design in subjects who receive at least one infusion of B7-H3CART. Each dose level will include 3 to 6 subjects, starting at Dose Level 1. If Dose Level 1 is considered too toxic, the dose may be de-escalated to Dose Level -1. If Dose Level 4 is completed with no dose limiting toxicity (DLT) in six subjects, a maximum tolerated dose (MTD) may not be determined, and Dose Level 4 will instead be the maximum administered dose (MAD). T

Dose ExpansionExperimental

After Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is established, a total of 12 evaluable subjects (including the 6 subjects infused during the dose escalation phase) will be enrolled at the RP2D to further explore safety of repeat administrations at MTD/RP2D and conduct a preliminary assessment of benefit.

Drugs: B7-H3CART

Sites

1 site in 1 country

  • Stanford Cancer InstitutePalo Alto, California, United States