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New treatment option for MCL
Official title Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
ClinicalTrials.gov ID: NCT06463691
What this study is testing
What is BGB-11417?
BGB-11417 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for mcl.
Also referred to as Sonrtotoclax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be ≥ 18 years of age.
- Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.
- Previously untreated MCL
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
- Nonsterile men and women of child-bearing potential must agree to use highly effective contraceptives (e.g., condoms, implants, injectables, combined...
You likely can't join if
- Subject has known central nervous system involvement by MCL.
- Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder...
- Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer)...
- Prior ASCT within the last 3 months; or prior autologous chimeric antigen receptor-T cell therapy within the last 3 months; or prior allogeneic stem...
- Major surgery within 4 weeks of screening.
- Clinically significant cardiovascular disease including the following:
See the full eligibility criteria
- Subject must be ≥ 18 years of age.
- Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.
- Previously untreated MCL
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
- Nonsterile men and women of child-bearing potential must agree to use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or...
- Subject must have adequate bone marrow function at Screening as follows: a.Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L (neutropenia due to marrow infiltration may be supported by growth factors);
- b. Platelets ≥ 75,000/mm3 (or ≥ 50,000/mm3 for patients with bone marrow involvement of lymphoma) within 7 days
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:
- aPTT and PT not to exceed 1.5 × the upper limit of normal (ULN); Serum creatinine not to exceed 2 x ULN, and a calculated creatinine clearance of at least 50 mL/min using the Cockcroft-Gault equation or a 24-hour urine...
- AST or ALT ≤ 3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin ≤ 1.5 × ULN. people with documented Gilbert's Syndrome may have a bilirubin \> 1.5 × ULN.
- Written informed consent form according to GCP and national regulations.
- Subject has known central nervous system involvement by MCL.
- Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason...
- Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug or requiring long-term use of...
- Prior ASCT within the last 3 months; or prior autologous chimeric antigen receptor-T cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active...
- Major surgery within 4 weeks of screening.
- Clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- New York Heart Association class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation)
- QT interval corrected based on Fridericia's formula (QTcF) \> 480 msec.
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
- Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg at screening.
- Prior exposure to a BCL2 inhibitor (e.g., venetoclax/ABT-199).
- Prior exposure to a BTK inhibitor (e.g., ibrutinib, zanubrutinib).
- History of hypersensitivity to excipient(s) of the sonrotoclax tablet.
- Patients with unresolved hepatitis B or C infection or known HIV-positive infection：
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\< 20 IU/mL), and...
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (\< 15 IU/mL), and if they are willing to undergo monitoring for HCV reactivation.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory...
- Pregnant or lactating women.
- History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or how well it works results.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.