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NCT05674175 · ClinicalTrials.gov registry record · Phase 1
Co-administration of CART22-65s and huCART19 for B-ALL
A Phase 1 study of B-cell Acute Lymphoblastic Leukemia and B Lineage Lymphoblastic Lymphoma, sponsored by Stephan Grupp MD PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 1
- Study location
NCT05674175: Recruiting Phase 1 study of B-cell Acute Lymphoblastic Leukemia and B Lineage Lymphoblastic Lymphoma, sponsored by Stephan Grupp MD PhD.
NCT05674175 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia and B Lineage Lymphoblastic Lymphoma that is actively recruiting participants, run by Stephan Grupp MD PhD. The registered enrollment target is 93 participants, roughly in line with the 85-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05674175, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia and B Lineage Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by Stephan Grupp MD PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).
Primary Outcome
The safety of the administering CART22-65s and huCART19 will be measured by the monitoring the frequency and severity of adverse events in patients with advanced or refractory B-Cell Acute Lymphoblastic Leukemia or B Cell Lymphoblastic Lymphoma (B-LLy), including those previously treated with cell therapy.
Conditions Studied
Interventions
- BIOLOGICAL Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)
- BIOLOGICAL Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2023-01-25 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 1 |
What NCT05674175 shows while recruiting
NCT05674175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, roughly in line with the 85-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target.
The record links to 2 conditions, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s) is the first listed.
NCT05674175 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05674175 about?
NCT05674175 is a clinical study titled "Co-administration of CART22-65s and huCART19 for B-ALL". This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).
What is the current status of trial NCT05674175?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2023-01-25. Estimated completion is 2029-01-15.
What conditions does trial NCT05674175 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia, B Lineage Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT05674175?
The interventions under investigation include: Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s) (BIOLOGICAL), Autologous, humanized anti-CD19 CAR T cell therapy (huCART19) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05674175?
This trial is sponsored by Stephan Grupp MD PhD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05674175 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05674175's enrollment target sits among peer trials
93 8th of 21 higher than 14 of 21 other B-cell Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell 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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