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

JRCT ID: jRCT2013190002

Registered date:28/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult relapsed /refractory B-ALL
• Date of first enrollment: 05/02/2020
• Target sample size: 30
• Countries of recruitment: UK,Japan,USA,Japan,France,Japan
• Study type: Interventional
• Intervention(s): UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients

Outcome(s)

• Primary Outcome: DLT (dose limiting toxicities) evaluation
• Secondary Outcome: Incidense and severity of adverse events etc

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

- Male or female participant
- Age from 18 years to 69 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

Exclude 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 Information

• Primary Sponsor: clinical operation department International center for therapeutic research
• Secondary ID(s): NCT02746952,JapicCTI-195059