Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
- Interventional
- Recruiting
- NCT04150497
Contact Information
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)
This is a Phase I, 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, tolerance, clinical activity of UCART22 and to determine the Maximum Tolerated Dose (MTD).
Gender
All
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers?
No
Inclusion Criteria:
1. Relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) after at least one standard chemotherapy regimen and one salvage regimen
2. Eastern Cooperative Oncology Group performance status of 0 or 1
3. No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy
1. Relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) after at least one standard chemotherapy regimen and one salvage regimen
2. Eastern Cooperative Oncology Group performance status of 0 or 1
3. No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy