A Phase 1 First-in-Human Dose Escalation Study of JNJ-67571244 (bispecific antibody targeting CD33 and CD3) in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Brief description of study

The purpose of this study is to see if there are doses of JNJ-67571244 (also referred to as ‘study drug’) that are both safe and effective in treating patients with Acute Myeloid Leukemia (AML) and high-risk or very high-risk Myelodysplastic Syndrome (MDS). This study will also look at the effects of the study drug on AML and MDS and any side effects that may be caused. JNJ-67571244 is an antibody intended to activate the body’s immune system by bringing your T cells (part of your immune system) and the cancer cells close together to aid in the killing of the cancer cells by your body’s immune system. JNJ-67571244 is an investigational (or experimental) drug that has not been used in humans before this study. This drug is experimental because it has not been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for the treatment of AML and/or MDS. JNJ-67571244 is not approved for use in any country. Therefore, it can only be used in a research study such as this one.


Clinical Study Identifier: s19-00790
ClinicalTrials.gov Identifier: NCT03915379
Principal Investigator: Mohammad Maher Abdul Hay.


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