Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia

B-cell Acute Lymphoblastic Leukemia Clinical Trial

— CALM  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02746952
• Other study ID #: CL1-68587-002
• Secondary ID: 2016-000296-24
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2016
• Est. completion date: July 28, 2020

Study information

• Verified date: September 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• UCART19

Locations

Country	Name	City	State
France	Hôpital Saint-Louis	Paris
France	Hôpital Saint-Antoine	PARIS Cedex 12
Japan	Kyushyu University Hospital	Fukuoka
Japan	Hokkaido University Hospital	Sapporo
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

United States,  France,  Japan,  United Kingdom, 

References & Publications (1)

Benjamin R, Graham C, Yallop D, Jozwik A, Mirci-Danicar OC, Lucchini G, Pinner D, Jain N, Kantarjian H, Boissel N, Maus MV, Frigault MJ, Baruchel A, Mohty M, Gianella-Borradori A, Binlich F, Balandraud S, Vitry F, Thomas E, Philippe A, Fouliard S, Dupouy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study.		Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12
Secondary	Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability	Adverse events assessed according to NCI-CTCAE v5.0 criteria	From inclusion to Month 12
Secondary	Objective Remission Rate	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)	At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12
Secondary	Duration of remission		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
Secondary	Time to remission		From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12
Secondary	Progression Free Survival (PFS)		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
Secondary	Overall Survival (OS)		From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12

External Links

•   Lay Summary
•   Results Summary