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NCT07671378 Sonrotoclax Chronic Lymphocytic Leukemia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

21 July 2026
8 min read

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Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07671378—A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07671378 is a hot trial to watch

Chronic Lymphocytic Leukemia is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07671378 is notable because it evaluates Sonrotoclax in a Phase 2 design while defined as the proportion of patients achieving undetectable minimal residual disease (MRD negativity, \<10-⁶) in peripheral blood as assessed by next-generation sequencing (NGS) serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

FieldIndexed detail
RegistrationNCT07671378
Official titleA Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL/SLL Patients
Phase / statusPhase 2 / Recruiting
InterventionSonrotoclax, Zanubrutinib, Zanubrutinib and sonrotoclax
SponsorThird Affiliated Hospital of Nanjing Medical University
CollaboratorsNot reported
GeographyChina
Enrollment24
Primary endpointdefined as the proportion of patients achieving undetectable minimal residual disease (MRD negativity, \<10-⁶) in peripheral blood as assessed by next-generation sequencing (NGS)
Endpoint time frameAt the end of Cycle 15 (each cycle is 28 days)
Primary completion / readout proxy[object Object]

Design and endpoint interpretation

The phase label is only the starting point. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 24 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

  • Primary: defined as the proportion of patients achieving undetectable minimal residual disease (MRD negativity, \<10-⁶) in peripheral blood as assessed by next-generation sequencing (NGS) (At the end of Cycle 15 (each cycle is 28 days))
  • Secondary: Overall response rate is the proportion of patients who achieve a complete response to treatment defined by the iwCLL. (On Day 1 of Cycle 7, Day 1 of Cycle 19, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, End of Treatment (each cycle is 28 days))
  • Secondary: PFS is defined as the time from the first dose of treatment to progression, or death due to any cause, whichever occurs first. For subjects without progression, relapse, or death at the time of analysis, EFS will be censored at the last assessment date. (From the first dose of treatment until the date of progression or date of death from any cause, whichever came first.assessed up to 3 years ( 36 month) .)
  • Secondary: OS is defined as the time from the first dose of treatment to death due to any cause. Subjects who remain alive at the time of analysis will be censored at the last known alive date of the subject. (lFrom the first dose of treatment until the date of death from any cause, whichever came first.assessed up to 3 years( 36 month) .)
  • Secondary: uMRD4 and uMRD6 rates assessed by flow cytometry and NGS after the actual end of combination therapy. (On Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, Day 1 of Cycle 25 (up to 25 cycles, each cycle is 28 days).)

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Benchmark readouts in the surrounding field

  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
  • A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
  • A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

Build a living trial monitor: connect to PatSnap MCP Servers and track status changes, endpoint revisions, primary-completion dates and newly indexed results without manually reconciling separate databases.

Asset and sponsor context

Drug & Asset context: Sonrotoclax (Approved; Bcl-2); Zanubrutinib (Approved; BTK)

Company & Deal Intelligence context: Third Affiliated Hospital of Nanjing Medical University — China — http://www.nysfy.cn

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

  • Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
  • Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
  • Sequencing evidence: comparative data after the most relevant contemporary standard of care.
  • Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
  • Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07671378 is a focused lens on Chronic Lymphocytic Leukemia development. Its value will be determined by whether Sonrotoclax can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.

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