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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03203369
Other study ID # UCART123_02
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 28, 2017
Est. completion date June 27, 2019

Study information

Verified date July 2019
Source Cellectis S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date June 27, 2019
Est. primary completion date June 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms

  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
  • Neoplasms

Intervention

Biological:
UCART123
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Cellectis S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence, nature, and severity of adverse events and serious adverse events Through day 84
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05645744 - Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
Completed NCT02113982 - SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia Phase 1/Phase 2
Active, not recruiting NCT04013685 - Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies Phase 1
Active, not recruiting NCT03599960 - Combination Chemotherapy in Patients With Newly Diagnosed BPDCN Phase 2
Recruiting NCT05430971 - Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry
Terminated NCT04109482 - Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. Phase 1/Phase 2
Recruiting NCT06006403 - Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm Phase 1/Phase 2