Clinical Trials

Sonrotoclax (BGB-11417) is being evaluated in numerous clinical trials spanning Phase 1 through Phase 3 to establish its safety, dosage, and therapeutic efficacy across various hematologic malignancies, including chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, relapsed or refractory multiple myeloma, and large B-cell lymphoma. Sponsored by industry entities such as BeOne Medicines alongside academic research centers, these protocols encompass active, recruiting, not yet recruiting, and completed statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06073821 ACTIVE_NOT_RECRUITING
CLL
BeOne Medicines
 2023-11-11 PHASE3
NCT07508995 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia (CLL)
M.D. Anderson Cancer Center
 2026-09-01 PHASE2
NCT07277231 RECRUITING
Chronic Lymphocytic Leukemia
BeOne Medicines
 2026-01-22 PHASE3
NCT07770698 NOT_YET_RECRUITING
Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; B-cell Acute Lymphoblastic Leukemia; Pediatric Cancer; Pediatric ALL, Relapsed; Pediatric ALL; Pediatric ALL, B Cell; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Pediatric AML; R/R AML; R/R B-cell ALL
BeOne Medicines
 2026-10 PHASE1; PHASE2
NCT06367374 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
 2024-05-30 PHASE2
NCT07682415 NOT_YET_RECRUITING
CLL / SLL
Yi Shuhua
 2026-06-08 PHASE2
NCT07341191 RECRUITING
Mantle Cell Lymphoma
Canadian Cancer Trials Group
 2026-08-24 PHASE2
NCT06697184 RECRUITING
Chronic Lymphocytic Leukemia; CLL; Mantle Cell Lymphoma; MCL
BeOne Medicines
 2025-01-23 PHASE1; PHASE2
NCT06854003 RECRUITING
Mantle Cell Lymphoma; Lymphoma
Christine Ryan
 2025-04-22 PHASE2
NCT06943872 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
BeOne Medicines
 2025-06-11 PHASE3
NCT07757672 NOT_YET_RECRUITING
AML (Acute Myelogenous Leukemia; HSCT
Institute of Hematology & Blood Diseases Hospital, China
 2026-09-01 PHASE1; PHASE2
NCT07548255 NOT_YET_RECRUITING
Intermediate-to-High-Risk Mantle Cell Lymphoma; the Efficacy and Safety
Ruijin Hospital
 2026-04-20 PHASE1
NCT06859008 RECRUITING
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3a Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Grade 1 Follicular Lymphoma; Refractory Grade 2 Follicular Lymphoma; Refractory Grade 3a Follicular Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma
City of Hope Medical Center
 2025-08-25 PHASE1
NCT07774234 NOT_YET_RECRUITING
Large B-Cell Lymphoma (LBCL); High-grade B-cell Lymphoma
The First Affiliated Hospital of Soochow University
 2026-08-20 PHASE2
NCT06634589 RECRUITING
B-cell Malignancy; Relapsed Cancer; Refractory Cancer; B-cell Lymphoma
BeOne Medicines
 2024-11-27 PHASE1; PHASE2
NCT06463691 RECRUITING
MCL
Tianjin Medical University Cancer Institute and Hospital
 2024-08-01 PHASE2
NCT07321652 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia
Alliance for Clinical Trials in Oncology
 2026-04-30 PHASE3
NCT07799220 NOT_YET_RECRUITING
Mantle Cell Lymphoma
Memorial Sloan Kettering Cancer Center
 2026-09 PHASE2
NCT06742996 RECRUITING
Mantle Cell Lymphoma; B Cell Lymphoma
BeOne Medicines
 2025-03-05 PHASE3
NCT06839053 RECRUITING
Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Mantle Cell Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Mantle Cell Lymphoma; Refractory Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma
Fred Hutchinson Cancer Center
 2025-06-02 PHASE2
NCT07550855 NOT_YET_RECRUITING
Follicular Lymphoma (FL)
Sun Yat-sen University
 2026-09-01 PHASE2
NCT06849713 RECRUITING
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma (SLL)
Massachusetts General Hospital
 2025-05-16 PHASE2
NCT07671378 RECRUITING
CLL (Chronic Lymphocytic Leukemia)
The First Affiliated Hospital with Nanjing Medical University
 2026-06-01 PHASE2
NCT07335887 RECRUITING
AL Amyloidosis (AL); t(11;14) Positive
Peking University People's Hospital
 2026-02-10 PHASE2
NCT06497062 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia
Shanghai Jiao Tong University School of Medicine
 2024-10-30 PHASE2
NCT07638787 NOT_YET_RECRUITING
Large B-cell Lymphoma
Ruijin Hospital
 2026-06-15 PHASE1; PHASE2
NCT07744750 NOT_YET_RECRUITING
DLBCL - Diffuse Large B Cell Lymphoma; Richter Transformation; CLL / SLL; MZL
Changzhou No.2 People's Hospital
 2026-08-30 PHASE2
NCT07687004 NOT_YET_RECRUITING
Multiple Myeloma (MM)
Institute of Hematology & Blood Diseases Hospital, China
 2026-08-01 PHASE1; PHASE2
NCT04271956 RECRUITING
Richter Transformation
German CLL Study Group
 2020-02-19 PHASE2
NCT07548710 RECRUITING
Acute Myeloid Leukemia
Ruijin Hospital
 2026-05-01 PHASE2
NCT04277637 ACTIVE_NOT_RECRUITING
Mature B-Cell Malignancies
BeOne Medicines
 2020-03-24 PHASE1
NCT07674810 NOT_YET_RECRUITING
Chronic Lymphocytic Leukemia
M.D. Anderson Cancer Center
 2026-12-31 PHASE2
NCT04973605 RECRUITING
Relapsed/Refractory Multiple Myeloma
BeOne Medicines
 2021-09-16 PHASE1; PHASE2
NCT06637501 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia
BeOne Medicines
 2024-11-14 PHASE2
NCT07628881 RECRUITING
Healthy Volunteers
BeOne Medicines
 2026-06-17 PHASE1
NCT05952037 ACTIVE_NOT_RECRUITING
Waldenstrom Macroglobulinemia; Waldenstrom's Macroglobulinemia Recurrent; Waldenstrom's Macroglobulinemia Refractory
BeOne Medicines
 2023-10-23 PHASE2
NCT07141511 COMPLETED
Healthy Volunteers
BeOne Medicines
 2025-09-24 PHASE1
NCT06543043 COMPLETED
Not Determined
BeiGene
 2024-08-19 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-07)

Check the Sonrotoclax (BGB-11417) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sonrotoclax is a potent and selective inhibitor that binds directly to B-cell lymphoma 2 (Bcl-2), blocking its anti-apoptotic interactions to restore mitochondrial outer membrane permeabilization and trigger programmed cell death in malignant cells. By neutralizing both wild-type Bcl-2 and the G101V mutant variant, this target-driven apoptosis effectively inhibits cellular proliferation, providing the mechanistic rationale for its ongoing clinical evaluation in patients with chronic lymphocytic leukemia, mantle cell lymphoma, and multiple myeloma.

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>).

Jump to

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