Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Start date: Feb 26, 2020 to May 26, 2020 Show 5 more changesShow less
    • Primary and study completion dates moved earlier to May 11, 2027
    • Interventions: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery) (Biological), Chlorotoxin… to Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery) (Biological), Chlorotoxin…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Study description revised
  2. Primary completion pushed from May 11, 2027 to Aug 20, 2027
    • Study completion pushed from May 11, 2027 to Jul 20, 2028
    v18
  3. Primary and study completion dates: Jun 9, 2026 to May 11, 2027v17
  4. Primary and study completion dates: Aug 31, 2025 to Jun 9, 2026v16
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 19
    • Site details revised
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Sep 1, 2024 to Aug 31, 2025v14
  2. Study completion date: Sep 25, 2025 to Aug 31, 2025v13
  3. Primary completion date: Aug 26, 2026 to Sep 1, 2024
    • Study completion date: Aug 26, 2026 to Sep 25, 2025
    v12
  4. Primary and study completion dates pushed to Aug 26, 2026v11
  5. Primary completion date: Dec 6, 2023 to Jan 2, 2024
    • Study completion date: Dec 6, 2023 to Dec 31, 2024
    v10
  6. Primary and study completion dates: Feb 6, 2023 to Dec 6, 2023v9
  7. Interventions: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (Biological) to Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery) (Biological), Chlorotoxin…
    • Eligibility criteria expanded, about 90 words
    • Study title revised
    • Study arms: 1 to 2
    v8
  8. Re-verified, no change to tracked fieldsv7
  9. Start date changed from estimate of May 1, 2020 to Feb 26, 2020v6 Show 6 more changesShow less
    • Interventions: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes NCI SYs (Biological) to Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (Biological)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 10 to 9
    • Site contact updated
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word
  10. Site contact updatedv5
  11. Start date: Mar 1, 2020 to May 1, 2020v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  13. Secondary endpoints: 9 to 10v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
City of Hope Medical Center
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This phase I trial studies the side effects and best dose of chimeric antigen receptor (CAR) T cells with a chlorotoxin tumor-targeting domain in treating patients with MPP2+ glioblastoma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
Trial Details
NCT Number NCT04214392
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma
Related terms Glioblastoma, Glioma
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov