Relapsed/Refractory Acute Myeloid Leukemia Clinical Trial
— AMELI-01Official title:
Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Cellectis S.A. |
United States,
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 |
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