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NCT05707273 · ClinicalTrials.gov registry record · Phase 1
CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission
A Phase 1 study of B Acute Lymphoblastic Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05707273: Active Phase 1 study of B Acute Lymphoblastic Leukemia, sponsored by City of Hope Medical Center.
NCT05707273 is a Phase 1 study of B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 1,026-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05707273, a Phase 1 study of B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (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 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 B-cell acute lymphoblastic leukemia.
Primary Outcome
Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, and reversibility or outcome.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Autologous Anti-CD19 CAR-expressing T Lymphocytes
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2026-07-24 |
| Phase | Phase 1 |
What the registry record for NCT05707273 still lists
NCT05707273 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 1,026-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05707273 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05707273 about?
NCT05707273 is a clinical study titled "CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission". This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (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 NCT05707273?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-04-26. Estimated completion is 2026-07-24.
What conditions does trial NCT05707273 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05707273?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Autologous Anti-CD19 CAR-expressing T Lymphocytes (DRUG).
Who is sponsoring clinical trial NCT05707273?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05707273 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
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Where NCT05707273's enrollment target sits among peer trials
18 20th of 20 higher than 1 of 20 other B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B Acute Lymphoblastic Leukemia 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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