Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03190278
Other study ID # UCART123_01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 19, 2017
Est. completion date December 2024

Study information

Verified date January 2024
Source Cellectis S.A.
Contact Cellectis Central Contact
Phone 1-347-752-4044
Email clinicaltrials@cellectis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Main Inclusion Criteria: - Patients with relapsed or primary refractory AML (as defined in World Health Organization [WHO] criteria) with =5% bone marrow blasts - Patients with CD123+ blast cells (verified by flow cytometry) - Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of =1 - Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period - (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD) - Other criteria may apply Main Exclusion Criteria: - Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia - Previous investigation gene or cell therapy (including CAR) - > 1 prior allogeneic stem cell transplantations (SCTs) - Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months - Any known active or uncontrolled infection - Other criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
UCART123v1.2
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Northwestern University Chicago Illinois
United States MD Anderson Cancer Center Houston Texas
United States Sylvester Comprehensive Cancer Center Miami Florida
United States Weill Medical College of Cornell University New York New York
United States University of Pennsylvania - Abramson Cancer Center Philadelphia Pennsylvania
United States University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center San Francisco California
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

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 of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability] Safety of UCART123v1.2 - Incidence, nature, and severity of AE and SAEs throughout the study 24 Months
Primary Dose escalation and expansion part: Occurrence of DLTs Up to Day 28 post last UCART123v1.2 infusion
Secondary Investigators assessed overall response rate according to the European Leukemia Net (ELN) Response Criteria At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
Secondary Duration of Response From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Secondary Progression Free Survival From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Secondary Overall Survival From the first day of study treatment to the date of death from any cause, assessed up to Month 24
Secondary Pharmacokinetic (PK) Analysis: Standard PK Analysis will be completed to obtain Maximum plasma concentration (Cmax) alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain time to reach Cmax (Tmax) alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain total area under curve from zero to infinity (AUC-infinity) alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain Terminal Rate alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain Terminal Half-life alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain Clearance alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacokinetic Analysis: Standard PK Analysis will be completed to obtain Volume of Distribution alemtuzumab levels will be determined pre- and post-dose alemtuzumab and up to 48 hours after the last dose
Secondary Pharmacodynamic Analysis: Pharmacodynamics Monitoring of the incidence of anti-cluster of differentiation 52 (anti-CD52; alemtuzumab) antibodies (ADA) in serum Pre-alemtuzumab administration and through Day 84 From screening through Day 84
Secondary Pharmacodynamic Analysis: Pharmacodynamics Quantitation of T cells in peripheral blood From screening through Day 84
Secondary Pharmacodynamic Analysis: Pharmacodynamics Quantitation of B cells in peripheral blood From screening through Day 84
Secondary Pharmacodynamic Analysis: Pharmacodynamics Quantitation of natural killer (NK) cells in peripheral blood From screening through Day 84
Secondary Pharmacodynamic Analysis: Pharmacodynamics Quantitation of total lymphocytes in peripheral blood From screening through Day 84
See also
  Status Clinical Trial Phase
Recruiting NCT05731219 - UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT05061147 - A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Phase 1/Phase 2
Not yet recruiting NCT05548088 - LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Terminated NCT03504410 - Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML Phase 3
Enrolling by invitation NCT05332054 - Long-Term Follow-up Study
Withdrawn NCT03904069 - Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML Phase 1
Completed NCT05518357 - LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Completed NCT02665143 - A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia Phase 2
Completed NCT03886831 - A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies Phase 1
Recruiting NCT05722171 - Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Completed NCT03318016 - Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT06084819 - Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Phase 2
No longer available NCT05627466 - US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia