Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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ClinicalTrials.gov Identifier: NCT04150497 |
Recruitment Status :
Recruiting
First Posted : November 4, 2019
Last Update Posted : May 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-cell Acute Lymphoblastic Leukemia | Biological: UCART22 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I, Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL) |
Actual Study Start Date : | October 14, 2019 |
Estimated Primary Completion Date : | October 14, 2022 |
Estimated Study Completion Date : | October 14, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation
Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified Dose Expansion: UCART22 administered at the MTD |
Biological: UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen |
- 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) after at least one standard chemotherapy regimen and one salvage regimen
- Eastern Cooperative Oncology Group performance status of 0 or 1
- No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150497
Contact: Cellectis Central Contact | +1 (347) 579-0635 | clinicaltrials@cellectis.com |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60647 | |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10065 | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Nitin Jain, MD | M.D. Anderson Cancer Center |
Responsible Party: | Cellectis S.A. |
ClinicalTrials.gov Identifier: | NCT04150497 |
Other Study ID Numbers: |
UCART22_01 |
First Posted: | November 4, 2019 Key Record Dates |
Last Update Posted: | May 28, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
B-cell Acute Lymphoblastic Leukemia (B-ALL) Relapse/Refractory B-ALL Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy Allogeneic Transcription Activator-Like Effector Nuclease (TALEN®) |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |