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

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) - CALM study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2013190002

Enrollment

Registered

2019-04-28

Start date

2020-02-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult relapsed /refractory B-ALL

Interventions

UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
DLT (dose limiting toxicities) evaluation	—

Secondary

Measure	Time frame
Incidense and severity of adverse events etc	—

Countries

France, Japan, UK, USA

Contacts

Public ContactInternational center for therapeutic research clinical operation department

Nihon Servier Company Limited

clinicaltrials.jpn@servier.com+81-3-5842-7160

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026