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Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN (ABC123)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203369
Recruitment Status : Terminated (The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.)
First Posted : June 29, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Study Description
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Brief Summary:
A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.

Condition or disease Intervention/treatment Phase
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Biological: UCART123 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open-label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
A single intravenous administration of UCART123. Dose escalation in Part 1 will include 3 doses ranging from 6.25 x 10^5 cells/kg to 6.25 x 10^6 cells/kg and continue until the Recommended Phase 2 Dose (RP2D) is identified.
 Biological: UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.
Experimental: Part 2: Dose Expansion
A single intravenous administration of UCART123 at the RP2D. 2 Cohorts: Patients with Relapsed/Refractory BPDCN and Newly Diagnosed BPDCN.
 Biological: UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence, nature, and severity of adverse events and serious adverse events [ Time Frame: Through day 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patients with a diagnosis BPDCN according to World Health Organization (WHO) classification confirmed by hematopathology;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203369


Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cellectis S.A.
Investigators
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Study Director: Ioana Kloos, MD Cellectis S.A.
More Information
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Responsible Party: Cellectis S.A.
ClinicalTrials.gov Identifier: NCT03203369    
Other Study ID Numbers: UCART123_02
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellectis S.A.:
Blastic plasmacytoid dendritic cell neoplasm
Natural Killer (NK) cell blastic lymphoma
Hematologic malignancies
Cluster of differentiation (CD) CD4+CD56+ hematodermic tumor
Acute leukemia and myeloid neoplasms
 Chimeric Antigen Receptor T-cell (CAR-T) therapy
Allogeneic
Cluster of differentiation 4 (CD4)
Cluster of differentiation 56 (CD56)
Additional relevant MeSH terms:
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Neoplasms