Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
- Conditions
- Adult relapsed /refractory B-A
- Registration Number
- JPRN-jRCT1080224971
- Lead Sponsor
- ihon Servier
- Brief Summary
This international, multicentre, open-label, dose-escalating, first in human CALM study was conducted in 25 adults with relapsed or refractory CD19 positive B-ALL to assess the safety and tolerability of ascending doses of UCART19, given as a single infusion (with the possibility of re-dosing). MTD was defined as the UCART19 DL3 (3 x 106 cells/kg) and the recommended dose was defined as the UCART19 DL2 (1 x 106 cells/kg).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 25
Male or female participant
- Age from 18 years
- Patient with relapsed or refractory CD19 positive B acute lymphoblastic leukaemia (B ALL) who have exhausted alternative treatment options
- Estimated life expectancy more than 12 weeks (according to investigator's judgement)
- Eastern Cooperative Oncology Group (ECOG) performance status under 2
- Previous treatment with gene or gene modified cell therapy medicine products or adoptive T cell therapy
- Use of previous anti leukemic therapy (including approved therapies and other investigational products) within 5 half lives prior to UCART19 administration
- CD19 negative B cell leukaemia
- Burkitt cell or mixed lineage acute leukaemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study.
- Secondary Outcome Measures
Name Time Method efficacy<br>exploratory<br>pharmacokinetics<br>safety<br>pharmacodynamics<br>pharmacogenomics<br>efficacy, pharmacokinetics, etc