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NCT04510051 · ClinicalTrials.gov registry record · Phase 1
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children
A Phase 1 study of Malignant Brain Neoplasm and Recurrent Malignant Brain Neoplasm, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT04510051: Recruiting Phase 1 study of Malignant Brain Neoplasm and Recurrent Malignant Brain Neoplasm, sponsored by City of Hope Medical Center.
NCT04510051 is a Phase 1 study of Malignant Brain Neoplasm and Recurrent Malignant Brain Neoplasm that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 228-participant average among 12 other Malignant Brain Neoplasm trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04510051, a Phase 1 study of Malignant Brain Neoplasm and Recurrent Malignant Brain Neoplasm, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.
Primary Outcome
Will assess the incidence of grade 3 toxicities, dose limiting toxicities, and all other toxicities. Toxicity and adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and the revised cytokine release syndrome (CRS) grading system. Symptoms and toxicities will be evaluated by physical exam and blood chemistry/hematology results and adverse event reporting. Rate and associated 90% Clopper and Pearson binomial confidence limits (90% CI) will b
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes
Study Locations (3)
California
- City of Hope Medical Center - Duarte
- Children's Hospital Los Angeles - Los Angeles
Michigan
- C.S. Mott Children's Hospital, University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2027-02-24 |
| Phase | Phase 1 |
What NCT04510051 shows while recruiting
NCT04510051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 228-participant average among 12 other Malignant Brain Neoplasm trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Malignant Brain Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04510051 reports a single indexed study location in California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04510051 about?
NCT04510051 is a clinical study titled "CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children". This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD...
What is the current status of trial NCT04510051?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-12-04. Estimated completion is 2027-02-24.
What conditions does trial NCT04510051 study?
This clinical trial studies the following conditions: Malignant Brain Neoplasm, Recurrent Malignant Brain Neoplasm, Refractory Malignant Brain Neoplasm.
What interventions are being tested in trial NCT04510051?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT04510051?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04510051 being conducted?
This trial has 3 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04510051's enrollment target sits among peer trials
18 13th of 12 the lowest of 12 other Malignant Brain Neoplasm trials
participants (enrollment target), bucketed by value
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