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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | UCART123v1.2 tested at several dose levels with different lymphodepletion regimens to establish Maximum Tolerated Dose (MTD) and identify Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART123v1.2 administered at the RP2D determined from the dose escalation phase |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCART123v1.2 | Biological | Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Dose escalation and expansion part: Occurrence of DLTs | Up to Day 28 post last UCART123v1.2 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Roboz, Dr | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | United States |
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| 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 |
| Overall Survival | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Pharmacodynamic Analysis: Pharmacodynamics Quantitation of T cells in peripheral blood | From screening through Day 84 |
| Pharmacodynamic Analysis: Pharmacodynamics Quantitation of B cells in peripheral blood | From screening through Day 84 |
| Pharmacodynamic Analysis: Pharmacodynamics Quantitation of natural killer (NK) cells in peripheral blood | From screening through Day 84 |
| Pharmacodynamic Analysis: Pharmacodynamics Quantitation of total lymphocytes in peripheral blood | From screening through Day 84 |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Northwestern University | Chicago | Illinois | 60201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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