Description:
This is a Phase 1, 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 and clinical activity
of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Title
- Brief Title: Phase 1 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
- Official Title: 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 1, 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 and clinical activity
of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Dose Escalation | Experimental | Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D)
Dose Expansion: UCART22 administered at the RP2D | |
Eligibility Criteria
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 60 days prior to
enrollment
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 15 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 |
Secondary Outcome Measures
| Measure: | Response Assessment determined using the response criteria as defined in NCCN guidelines version 1.2020 for Acute Lymphoblastic Leukemia |
| Time Frame: | At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24 |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response |
| Time Frame: | From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24 |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival |
| Time Frame: | From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24 |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival |
| Time Frame: | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Cellectis S.A. |
Trial Keywords
- 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®)
Last Updated
June 10, 2021
