A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: I (Cancer Control)
Principal Investigator: Kallam, Avyakta
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03900598?term=NCT03900598&draw=2&rank=1#eligibility
Summary
Primary: Part 1 (Dose Escalation) and Cohort 6 (Part 2); Determine the RP2D(s) regimen or the MTD of JNJ-67856633 in participants with relapsed/ refractory B-cell NHL and CLL, Part 2 (Cohort Expansion); Evaluate the safety of JNJ-67856633 at the RP2D regimen in participants with relapsed/refractory B-cell NHL and CLL. Secondary: Assess the PK of JNJ-67856633, Assess the PD of JNJ-67856633, Evaluate the preliminary clinical activity of JNJ-67856633 in participants with relapsed/refractory B-cell NHL and CLL. Exploratory: Minimal residual disease assessment in CLL, Explore biomarkers of response to JNJ-67856633 which may include, but are not limited to, mutation and expression profile associated with response/resistance, cytokine profile, and immune cell subsets, Explore the relationships between PK, PD, biomarkers, adverse event profiles, and clinical activity or resistance to JNJ-67856633, To explore the effect of a high-fat meal on the pharmacokinetics of JNJ-67856633.