A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT03915379|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Myelodysplastic Syndromes||Drug: JNJ-67571244||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-67371244 (Bispecific Antibody Targeting CD33 and CD3), in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||June 4, 2021|
|Estimated Study Completion Date :||January 25, 2022|
Experimental: Part 1: Dose Escalation
Participants will receive JNJ-67571244. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
JNJ-67571244 will be administered.
Experimental: Part 2: Dose Expansion
Participants in 2 expansion cohorts of acute myeloid leukemia (AML) or either high-risk myelodysplastic syndromes (MDS) or very high-risk MDS will receive JNJ-67571244 at the RP2D determined in Part 1.
JNJ-67571244 will be administered.
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 100 days after the last dose of study drug or until the start of a subsequent anticancer therapy, whichever comes first (that is up to 2.3 years) ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) [ Time Frame: Up to 28 days ]Number of participants with dose-limiting toxicity will be assessed. The DLTs are based on drug-related adverse events and defined as any of the following events: infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or hematologic toxicity.
- Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Up to 28 days ]The DLT evaluation period is defined as the first 28 days after a participant's first infusion (Day 1). Severity criteria is based on Grade 1, 2, 3, 4 and 5, will be assessed by the investigator as per below grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.
- Part 2: Overall Response Rate (ORR) [ Time Frame: Approximately 2.3 years ]ORR is defined as the percentage of participants who have complete response (CR) and incomplete blood count recovery (CRi) (AML) or CR and partial response (PR) (MDS) as per modified International Working Group response (IWGR) criteria.
- Part 1 and Part 2: Serum Concentrations of JNJ-67571244 [ Time Frame: Approximately 2.3 years ]Serum samples will be analyzed to determine concentrations of JNJ-67571244 using a validated immunoassay method.
- Part 1 and 2: Systemic Cytokine Concentrations [ Time Frame: Approximately 2.3 years ]Serum cytokine (Interleukin [IL]-2, IL-6, IL-8, IL-10, and Interferon [IFN]-alpha, IFN-delta with same unit of measurement) concentrations will be measured for biomarker assessment.
- Number of Participants with Depletion of CD33-Expressing Cells [ Time Frame: Approximately 2.3 years ]Number of participants with depletion of CD33-expressing cells will be assessed.
- Part 1 and 2: Concentration of Markers of T-Cell Activation [ Time Frame: Up to 24 days ]Levels of T-cell activation marker CD25 will be reported as measured by flow cytometry and cytometry by time of flight (CyTOF). T-cell activation will also be assessed by measuring cytokine release.
- Part 1 and 2: Number of Participants with JNJ-67571244 Antibodies [ Time Frame: Week 1 (Day 1) up to post treatment Week 8 ]Anti-JNJ-67571244 antibodies will be evaluated in serum samples collected from all participants and the titer of confirmed positive samples will be reported.
- Part 1 and Part 2: Duration of response (DOR) [ Time Frame: Approximately 2.3 years ]DOR is calculated from date of initial documentation of a response (complete response (CR) and incomplete blood count recovery (CRi) (AML) or CR and partial response (PR) [MDS]) to the date of first documented evidence of relapse, defined in disease-specific response criteria, or death, whichever occurs first.
- Part 1 and Part 2: Time to response (TTR) [ Time Frame: Approximately 2.3 years ]TTR defined for the responders as the time from the date of first dose of study drug to the date of initial documentation of a response (CR and CRi [AML] or CR and PR [MDS]), as defined in the disease-specific response criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915379
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|