Description:
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).
Title
- Brief Title: Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
- 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)
Clinical Trial IDs
- ORG STUDY ID:
UCART22_01
- NCT ID:
NCT04150497
Conditions
- B-cell Acute Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
UCART22 | | Dose Escalation |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Part 1: Dose Escalation One administration of UCART22 in the dose escalation phase will explore 4 doses of UCART22 and continue until the Maximum Tolerated Dose (MTD) is identified.
Part 2: Dose Expansion One administration of UCART22 at the MTD. | |
Eligibility Criteria
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
Maximum Eligible Age: | 65 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of AE/SAE/DLT [Safety and Tolerability) |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Cellectis S.A. |
Trial Keywords
- BALLI-01
- B-cell Acute Lymphoblastic Leukemia (B-ALL)
- Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy
- Allogeneic
- Transcription Activator-Like Effector Nuclease (TALEN®)
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