UCART22_01
Research type
Research Study
Full title
Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneicengineered T-cells expressing Anti-CD22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
IRAS ID
1012873
Contact name
Stephan Reynier
Contact email
Sponsor organisation
Cellectis S.A.
Clinicaltrials.gov Identifier
Research summary
This study will evaluate the safety and tolerability of UCART22, a type of genetically modified immune cell known as
chimeric antigen receptor (CAR) T-cell, in patients with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (BALL).
B-ALL is a life threatening form of blood cancer that can return after treatment or fail to respond to standard
therapies. UCART22 is an “off-the-shelf” cell therapy, meaning the T-cells are collected from healthy donors engineered in a lab to recognize and bind to a marker on the surface of B-ALL cells called CD22. Once administered,
these modified T-cells aim to seek out and kill the cancerous cells. Before receiving the UCART22 cells, all patients
will receive a short course of chemotherapy, over 3 days (e.g., Lymphodepletion regimen) to help the UCART22 cells
work more effectively. The lymphodepletion reduces the number of immune cells in the body, creating space for the
UCART22 cells to expand and attack the cancer cells. Patients will be admitted to hospital and will receive the short
course of chemotherapy followed by the administration of one dose of UCART22 cells. Patients will be admitted to the
hospital from lymphodepletion through D14. Patients will be discharged once they are deemed fit and well enough for
outpatient care and followed up in the outpatient setting. As the study enrolls the safety and the effectiveness of the
therapy will be periodically reviewed and changes may be made based on these reviews. to serve the best interest of the
patients.REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0099
Date of REC Opinion
27 May 2026
REC opinion
Further Information Favourable Opinion