The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL

Sponsor
Ruijin Hospital
Study ID
NCT07548255
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Intermediate-to-High-Risk Mantle Cell Lymphoma
  • the Efficacy and Safety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonrotoclax, Zanubrutinib Combined with Obinutuzumab — DRUG
    The treatment regimen was as follows: In cycle 1 (C1), obinutuzumab 1000 mg was administered intravenously on day 1 (D1); sotoroclax was given at 80 mg on D2, 160 mg on D3, and 320 mg on D4; zanubrutinib was administered at 160 mg twice daily (BID). Each cycle was defined as 28 days. From cycles 2 to 6 (C2-C6), patients received obinutuzumab 1000 mg intravenously on D1, sotoroclax 320 mg once daily, and zanubrutinib 160 mg BID.

Study Details

A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment

Primary Outcome Measure

Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]

Central Contacts