B-cell Acute Lymphoblastic Leukemia
Conditions
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®)
Brief summary
This is a 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)
Interventions
Sponsors
Cellectis S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No
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 90 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE/SAE/DLT [Safety and Tolerability] | 24 Months | Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion |
| Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) | Up to D28 post initial UCART22 infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 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 |
| Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL) | At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24 |
| Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion | Lymphodepletion to Day 56 |
| Overall Survival | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 |
| Duration of Response | 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 |
Countries
France, United States
Contacts
Primary ContactCellectis Central Contact
Outcome results
None listed