Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Phase 1
Recruiting
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Registration Number
- NCT04150497
- Lead Sponsor
- Cellectis S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - B-ALL blast cells expressing CD22<br><br> - Diagnosed with R/R B-ALL<br><br> - Prior therapy must include at least one standard chemotherapy regimen and at least<br> one salvage regimen<br><br>Exclusion Criteria:<br><br>-Prior cellular therapy or investigational cellular or gene therapy within 60 days prior<br>to enrollment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of AE/SAE/DLT [Safety and Tolerability];Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL);Duration of Response;Progression Free Survival;Overall Survival;Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion