Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting Phase 1 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Cellectis S.A..

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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)

Primary Outcome

Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion

Conditions Studied

B-cell Acute Lymphoblastic Leukemia

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
Cellectis S.A.

5 total trials

What NCT04150497 shows while recruiting

NCT04150497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 86-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (40% lower).

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 lists 19 locations in 10 states (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.

Learn More About Clinical Trials

Similar trials for B-cell Acute Lymphoblastic Leukemia

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 NCT04150497's enrollment target sits among peer trials

52 13th of 21 higher than 9 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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02630121 · 52 participants · Phase 4

    Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

  • NCT03629171 · 52 participants · Phase 2

    Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

  • NCT04128748 · 52 participants · Phase 1

    Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

  • NCT04150640 · 52 participants · Phase 2

    Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT04150497

Source: ClinicalTrials.gov NCT04150497, the US trial registry maintained by the National Library of Medicine. NCT04150497 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.