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NCT04214392 · ClinicalTrials.gov registry record · Phase 1
Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma
A Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04214392: Active Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by City of Hope Medical Center.
NCT04214392 is a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 19 participants, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04214392, a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence interval) will be estimated for participants experiencing DLTs at the recommended phase 2 dose schedule. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity, and arm. 2. Cytokine Release Syndrome (CRS) 3. All other toxicities.
Conditions Studied
Interventions
- BIOLOGICAL Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery)
- BIOLOGICAL Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery)
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2026-06-09 |
| Phase | Phase 1 |
What the registry record for NCT04214392 still lists
NCT04214392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (72% lower).
The record links to 4 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery) is the first listed.
NCT04214392 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04214392 about?
NCT04214392 is a clinical study titled "Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma". 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...
What is the current status of trial NCT04214392?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-02-26. Estimated completion is 2026-06-09.
What conditions does trial NCT04214392 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade III Glioma, Recurrent WHO Grade II Glioma.
What interventions are being tested in trial NCT04214392?
The interventions under investigation include: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery) (BIOLOGICAL), Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04214392?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04214392 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04214392's enrollment target sits among peer trials
19 47th of 62 higher than 16 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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