The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
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Number of Participants With DLTs
Timeframe: Cycle 1 (28 days)
Percent Change From Baseline in Immunoglobulin M (IgM) at Cycle 1
Timeframe: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 2
Timeframe: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 3
Timeframe: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Percent Change From Baseline in Hemoglobin (Hgb) at Cycle 1
Timeframe: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 2
Timeframe: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 3
Timeframe: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Cmax of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Time to Reach Cmax (Tmax) of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Tmax of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Half-Life (t1/2) of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
t1/2 of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Area Under the Concentration-Time Curve (AUC) of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
AUC of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Volume of Distribution (Vd) of Mavorixafor
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Vd of Ibrutinib
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Change From Baseline in AUC of Absolute Neutrophil Count (ANC) at Cycle 1
Timeframe: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 2
Timeframe: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 3
Timeframe: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 1
Timeframe: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 2
Timeframe: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 3
Timeframe: Baseline, at the end of Cycle 3 (cycle length = 28 days)