Clinical Trials

Numerous clinical trials evaluate the therapeutic potential of nemtabrutinib across Phase 1 through Phase 3 studies for B-cell malignancies and hematological disorders, including chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, and Waldenström's macroglobulinemia. Sponsored by pharmaceutical leaders such as Merck Sharp & Dohme alongside academic institutions like City of Hope and Roswell Park Cancer Institute, these studies range in status from actively recruiting and active not recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06136559 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Merck Sharp & Dohme LLC
 2023-12-13 PHASE3
NCT05947851 RECRUITING
Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Chronic Lymphocytic; Small-Cell Lymphoma; Lymphoma, Small Lymphocytic; CLL; SLL
Merck Sharp & Dohme LLC
 2023-08-08 PHASE3
NCT07673367 RECRUITING
Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma
Vanderbilt-Ingram Cancer Center
 2026-07-31 PHASE2
NCT07796373 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia
National Heart, Lung, and Blood Institute (NHLBI)
 2026-09-09 PHASE2
NCT07690891 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia
Medical College of Wisconsin
 2026-10-01 PHASE2
NCT07194980 RECRUITING
Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Fred Hutchinson Cancer Center
 2026-09-01 PHASE2
NCT07464210 NOT_YET_RECRUITING
Waldenstrom Macroglobulinemia
Seoul National University Hospital
 2026-06-01 PHASE2
NCT06863402 RECRUITING
Richter Syndrome; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia
Roswell Park Cancer Institute
 2026-08-15 PHASE2
NCT05458297 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Follicular Lymphoma; Richter Transformation Lymphoma
Merck Sharp & Dohme LLC
 2022-07-21 PHASE2
NCT04728893 RECRUITING
Hematologic Malignancies; Waldenstroms Macroglobulinaemia; Non-Hodgkins Lymphoma; Chronic Lymphocytic Leukaemia
Merck Sharp & Dohme LLC
 2021-04-05 PHASE2
NCT07583810 NOT_YET_RECRUITING
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma; Gastric Mucosa-Associated Lymphoid Tissue Lymphoma; Marginal Zone Lymphoma; Nodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; Lymphoma; Extranodal Marginal Zone Lymphoma
City of Hope Medical Center
 2026-12-16 PHASE2
NCT07557056 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Jennifer Woyach
 2026-09-01 PHASE2
NCT03162536 ACTIVE_NOT_RECRUITING
Lymphoma, B-Cell; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma; Richter's Transformation; Follicular Lymphoma; Marginal Zone Lymphoma
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
 2017-06-26 PHASE1; PHASE2
NCT05624554 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Merck Sharp & Dohme LLC
 2023-03-16 PHASE3
NCT05347225 ACTIVE_NOT_RECRUITING
Hematological Malignancies
Merck Sharp & Dohme LLC
 2022-06-09 PHASE1
NCT07734610 NOT_YET_RECRUITING
Severe Renal Impairment; Healthy
Merck Sharp & Dohme LLC
 2026-08-17 PHASE1
NCT06572618 RECRUITING
Mantle Cell Lymphoma
City of Hope Medical Center
 2025-01-22 PHASE2
NCT06442436 COMPLETED
Hepatic Impairment (HI)
Merck Sharp & Dohme LLC
 2024-07-24 PHASE1
NCT07232589 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2025-12-08 PHASE1
NCT05673460 COMPLETED
Mature B-cell Neoplasms
Merck Sharp & Dohme LLC
 2023-02-13 PHASE1
NCT06625827 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-11-07 PHASE1
NCT06688045 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-10-30 PHASE1
NCT06772818 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-10-02 PHASE1
NCT06772805 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-07-24 PHASE1
NCT06586671 COMPLETED
Hematological Malignancy
Merck Sharp & Dohme LLC
 2023-08-28 PHASE1
NCT06698016 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-07-25 PHASE1
NCT05673460 Active not recruiting
Mature B-cell Neoplasms
Merck Sharp & Dohme LLC
 2023-02-13 Phase 1
NCT05347225 Active not recruiting
Hematological Malignancies
Merck Sharp & Dohme LLC
 2022-06-09 Phase 1
NCT04728893 Recruiting
Hematologic Malignancies|Waldenstroms Macroglobulinaemia|Non-Hodgkins Lymphoma|Chronic Lymphocytic Leukaemia
Merck Sharp & Dohme LLC
 2021-04-05 Phase 2
NCT03162536 Active not recruiting
Lymphoma B-Cell|Small Lymphocytic Lymphoma|Chronic Lymphocytic Leukemia|Waldenstrom Macroglobulinemia|Mantle Cell Lymphoma|Diffuse Large B Cell Lymphoma|Richter''s Transformation|Follicular Lymphoma|Marginal Zone Lymphoma
ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)
 2017-06-26 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the Nemtabrutinib (ARQ 531) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nemtabrutinib functions as an ATP-competitive inhibitor that selectively binds Bruton's tyrosine kinase (BTK) alongside key TEC, Trk, and Src family kinases. Blocking this kinase activity shuts down downstream B-cell receptor signaling cascades, which halts proliferation and induces apoptosis in malignant lymphocytes to inhibit tumor growth in hematological conditions such as chronic lymphocytic leukemia and non-Hodgkin lymphomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.