NCT04150497 · Cellectis S.A.
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
What this study is about
This is a first-in-human, where both patients and doctors know the treatment given, gradually increasing doses and expansion study of UCART22 administered given through a vein (IV) to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL).
View original scientific description
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).
Interventions
BIOLOGICAL
UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
BIOLOGICAL
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Primary outcome measures
Incidence of AE/SAE/DLT [Safety and Tolerability]
Time frame: 24 Months
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: Up to D28 post initial UCART22 infusion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- B-ALL blast cells expressing CD22
- Diagnosed with R/R B-ALL
- Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen
Exclusion criteria
- -Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
Where
- Los Angeles, California
- Aurora, Colorado
- Denver, Colorado
- Chicago, Illinois
- Boston, Massachusetts
- Buffalo, New York
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Austin, Texas
- Houston, Texas
- San Antonio, Texas
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations