Description:
The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the
dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19
(dose-escalation part) given as a single infusion in patients with relapsed / refractory
(R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose
(MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose
expansion is to assess the safety and tolerability of the RD for UCART19.
Title
- Brief Title: Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
- Official Title: Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)
Clinical Trial IDs
- ORG STUDY ID:
CL1-68587-002
- SECONDARY ID:
2016-000296-24
- NCT ID:
NCT02746952
Conditions
- B-cell Acute Lymphoblastic Leukemia
Interventions
| Drug | Synonyms | Arms |
|---|
| UCART19 | S68587 | UCART19 |
Purpose
The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the
dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19
(dose-escalation part) given as a single infusion in patients with relapsed / refractory
(R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose
(MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose
expansion is to assess the safety and tolerability of the RD for UCART19.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| UCART19 | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Male or female participant
- Age ≥ 16 years
- Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia
(B-ALL) who have exhausted alternative treatment options
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
Exclusion Criteria:
- 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
| Maximum Eligible Age: | 69 Years |
| Minimum Eligible Age: | 16 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study. |
| Time Frame: | Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability |
| Time Frame: | From inclusion to Month 12 |
| Safety Issue: | |
| Description: | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
| Measure: | Objective Remission Rate |
| Time Frame: | At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12 |
| Safety Issue: | |
| Description: | Proportion of patients in whom a response among molecular complete remission (mCR), morphologic complete remission (CR) and complete remission with incomplete blood count recovery (CRi) |
| Measure: | Duration of remission |
| Time Frame: | From the time that response criteria are first met until the date of progression or death (whatever the reason of death), whichever occurs first, assessed up to Month 12 |
| Safety Issue: | |
| Description: | |
| Measure: | Time to remission |
| Time Frame: | From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12 |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | From the date of UCART19 administration until the date of progression or the date of death (whatever the reason of death), whichever occur first, assessed up to Month 12 |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival (OS) |
| Time Frame: | From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Institut de Recherches Internationales Servier |
Last Updated
December 24, 2020
