Natural Killer Cell (CYNK-001) Infusions in Adults With AML (CYNK001AML01)
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|ClinicalTrials.gov Identifier: NCT04310592|
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Alkylating Agents Antimetabolites, Antineoplastic Antiviral Agents Analgesics, Non-narcotic Anti-infective Agents Analgesics Peripheral Nervous System Agents Hematologic Diseases Hematologic Neoplasms Leukemia in Remission||Biological: CYNK-001||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Experimental: Cyclophosphamide + Fludarabine + CYNK-001. On Days 0, 7, and 14, CYNK-001 at 3 varying dose levels.|
|Masking:||None (Open Label)|
|Official Title:||Phase I Multi-dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults With Primary or Secondary AML in Morphologic Complete Remission With Minimal Residual Disease|
|Actual Study Start Date :||March 12, 2020|
|Estimated Primary Completion Date :||January 3, 2022|
|Estimated Study Completion Date :||January 3, 2022|
Experimental: Dose escalation/MTD or MPD determination
Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.
CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
- Number of Participants who experience a Dose-limiting Toxicity (DLT) [ Time Frame: Day +28 ]The number of participants who experience a DLT will be measured.
- Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 [ Time Frame: up to 28 days ]The maximum dose safely administered for the treatment of patients with AML.
- Frequency and Severity of Adverse Events (AEs) [ Time Frame: up to 12 months ]Frequency and severity of Adverse Events will be evaluated.
- Number of Participants who experience Minimal Residual Disease (MRD) Response [ Time Frame: up to 12 months ]The number of participants who convert from MRD positive to MRD negative.
- Time to MRD Response [ Time Frame: up to 12 months ]The time it takes to convert from MRD positive to MRD negative.
- Duration of MRD Response [ Time Frame: up to 12 months ]The measure of how long participants remain MRD negative.
- Progression-free Survival (PFS) [ Time Frame: up to 12 months ]Date of first CYNK-001 infusion to date of disease progression.
- Time to Progression (TTP) [ Time Frame: up to 12 months ]Date of first CYNK-001 infusion to date of disease progression.
- Duration of Morphologic Complete Remission (CR) [ Time Frame: up to 12 months ]Duration from first Morphologic CR observation to time of disease progression.
- Overall Survival (OS) [ Time Frame: up to 12 months ]Date of first CYNK-001 infusion to date of death.
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): NCT04310592
|Contact: Erica Rave, MSemail@example.com|
|Contact: Solveig Ericson, MD, PhDfirstname.lastname@example.org|
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|Study Director:||Solveig Ericson, MD, PhD||Celularity, Inc.|