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NCT04150497 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
A Phase 1 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Cellectis S.A..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 19
- Study locations
NCT04150497 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Cellectis S.A.. The registered enrollment target is 52 participants, below the 86-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (40% lower). The trial reports 19 study locations across 10 states.
The verdict
NCT04150497, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Cellectis S.A..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 19
- Study locations
Study Summary
This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Conditions Studied
Interventions
- BIOLOGICAL UCART22
- BIOLOGICAL CLLS52
Study Locations (19)
Other
- CHU de Nantes - Hôtel-Dieu - Nantes
- Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie - Paris
- Hôpital Robert Debré - Service d'hémato-immunologie - Paris
- Hôpital Lyon Sud - Pierre-Bénite
- CHU Rennes - Hopital Pontchaillou - Rennes
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center - New York
- Weill Medical College of Cornell University - New York
Texas
- Sarah Cannon - St. David's South Austin Medical Center - Austin
- MD Anderson Cancer Center - Houston
- Sarah Cannon - Texas Transplant Institute at Methodist Hospital - San Antonio
Colorado
- University of Colorado - Aurora Cancer Center - Aurora
- Sarah Cannon - Colorado Blood Cancer Institute - Denver
California
- University of California, Los Angeles (UCLA) - Medical Center - Los Angeles
Illinois
- University of Chicago - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04150497
The ClinicalTrials.gov registry entry for NCT04150497 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (40% lower). The listed sponsor is Cellectis S.A., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which UCART22 is the first listed.
NCT04150497 reports 19 study locations spanning 10 distinct geographic areas - top geographies include Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT04150497 about?
NCT04150497 is a clinical study titled "Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)". This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the ...
What is the current status of trial NCT04150497?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2019-10-14. Estimated completion is 2026-06-30.
What conditions does trial NCT04150497 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04150497?
The interventions under investigation include: UCART22 (BIOLOGICAL), CLLS52 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04150497?
This trial is sponsored by Cellectis S.A., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04150497 being conducted?
This trial has 19 study locations across California, Colorado, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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