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RECRUITING Phase 1

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

NCT04150497 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 52 participants
Start Date 2019-10-14
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Cellectis S.A.

3 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cellectis S.A., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04150497 reports 19 study locations spanning 10 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04150497?

The interventions under investigation include: UCART22 (BIOLOGICAL), CLLS52 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04150497?

This trial is sponsored by Cellectis S.A., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial