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NCT05625594 · ClinicalTrials.gov registry record · Phase 1
Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/Mem T-lymphocytes) for the Treatment of Central Nervous System Lymphoma
A Phase 1 study of Central Nervous System Lymphoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05625594: Recruiting Phase 1 study of Central Nervous System Lymphoma, sponsored by City of Hope Medical Center.
NCT05625594 is a Phase 1 study of Central Nervous System Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 20 participants, below the 104-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05625594, a Phase 1 study of Central Nervous System Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.
Primary Outcome
Will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0, particularly dose-limiting toxicities (DLTs), cytokine release syndrome (CRS) based on the revised CRS grading system by American Society for Transplantation and Cellular Therapy Consensus Criteria, and all other toxicities. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated for participants experiencing DLTs, each type of cytopenia, disease re
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Aspiration
- PROCEDURE Catheterization
- BIOLOGICAL CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem T-lymphocytes
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-06-29 |
| Est. Completion | 2026-05-21 |
| Phase | Phase 1 |
What NCT05625594 shows while recruiting
NCT05625594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 104-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Central Nervous System Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05625594 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05625594 about?
NCT05625594 is a clinical study titled "Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/Mem T-lymphocytes) for the Treatment of Central Nervous System Lymphoma". This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a typ...
What is the current status of trial NCT05625594?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-06-29. Estimated completion is 2026-05-21.
What conditions does trial NCT05625594 study?
This clinical trial studies the following conditions: Central Nervous System Lymphoma.
What interventions are being tested in trial NCT05625594?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Aspiration (PROCEDURE), Catheterization (PROCEDURE), CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem T-lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT05625594?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05625594 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 Central Nervous System Lymphoma
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 NCT05625594's enrollment target sits among peer trials
20 11th of 14 higher than 4 of 14 other Central Nervous System Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Central Nervous System Lymphoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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