Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients

NCT06463691 | Recruiting Phase 2 DMC

• 1 other identifier: BGB-11417- 2003-IIT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MCL

Keywords

MCL; Sonrotoclax; Zanubrutinib

Outcome Measures

Primary Outcomes (1)

• CR (complete response) rate at cycle 12 by investigator (INV).

  Complete response rate (CRR) of the study population from the initiation of the first cycle treatment. CRR is defined as the proportion of patients that achieved the best response of CR, determined by INV.

  From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)

Secondary Outcomes (2)

• ORR (Overall response rate)

  From enrollment to the end of treatment at the end of cycle 36 (each cycle is 28 days)

• Overall survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Sonrotoclax, orally, 320 mg once daily following ramp-up. Zanubrutinib, orally, 320 mg total daily dose. CD20mab, which is recommended Rituximab, 375mg/m2, from C1 to C12

Drug: BGB-11417; Drug: BGB-3111; Drug: CD20

Interventions

BGB-11417 DRUG

Sonrotoclax, orally, 320 mg once daily following a weekly ramp-up schedule

Also known as: Sonrtotoclax

Treatment arm

BGB-3111 DRUG

Zanubrutinib, orally, 320 mg total daily dose

Also known as: Zanubrutinib

Treatment arm

CD20 DRUG

CD20mab is recommened as Rituximab as per the protocol, other CD20mab is also allowed.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.
• 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 collection;
• AST or ALT ≤ 3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's Syndrome may have a bilirubin \> 1.5 × ULN.
• Written informed consent form according to GCP and national regulations.

You may not qualify 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 cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
• 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 strong CYP3A4 inhibitors or inducers.
• 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 graft-vs-host disease requiring the use of immunosuppressants.
• 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).

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Interventions

zanubrutinib

Central Study Contacts

Huilai Zhang, MD, PhD

CONTACT

0086-22-23359337; info@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sonrotoclax, Zanubrutinib and CD20mab

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CN (1)