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

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Servier

Status and phase

Completed
Phase 1

Conditions

B-cell Acute Lymphoblastic Leukemia

Treatments

Biological: UCART19

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02746952
2016-000296-24 (EudraCT Number)
CL1-68587-002

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

16 to 69 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

UCART19
Experimental group
Treatment:
Biological: UCART19

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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