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Completed

NCT Number: NCT02746952

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

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.

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Key information

Conditions

B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

16 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Saint-Antoine, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCART19

Biological

Other names: S68587

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

    Time frame: From inclusion to Month 12

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Objective Remission Rate

    Time frame: At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12

    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)

  3. 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

  4. Time to remission

    Time frame: From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12

  5. 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

  6. Overall Survival (OS)

    Time frame: From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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)

Acronym: CALM

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2016
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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