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OncoMatch/Clinical Trials/NCT06978088

LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This

Is NCT06978088 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LP-168 and Obinutuzumab for chronic lymphocytic leukemia/small lymphocytic lymphoma.

Phase 2RecruitingZulfa OmerNCT06978088Data as of May 2026

Treatment: LP-168 · ObinutuzumabMulticenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This.

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Extracted eligibility criteria

Cancer type

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: BTK gatekeeper mutation in the T474 coordinate

have a BTK gatekeeper mutation in the T474 coordinate

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

ECOG performance status ≤2 (or Karnofsky ≥60%)

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

ANC ≥1,000/mcL (unless due to underlying CLL bone marrow disease); Platelets ≥ 50,000/µL (unless due to underlying CLL bone marrow disease then ≥20,000 acceptable)

Kidney function

Estimated glomerular filtration rate ≥ 30 mL/min

Liver function

Total bilirubin ≤1.5 x ULN (except Gilbert's syndrome); AST and ALT ≤2.5 × ULN

Cardiac function

No significant cardiovascular disease; left ventricular ejection fraction > 40%; no Class 3 or 4 cardiac disease per NYHA

Patients must have adequate organ and marrow function as defined below: ANC ≥1,000/mcL, unless if neutropenia is due to underlying CLL bone marrow disease. Platelets ≥ 50,000/ µL unless if thrombocytopenia is due to underlying CLL bone marrow disease then platelets of ≥20,000 is acceptable. Total bilirubin ≤1.5 x ULN (excepting Gilbert's syndrome). AST and ALT ≤2.5 × ULN. Estimated glomerular filtration rate ≥ 30 mL/min. Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Cincinnati Medical Center · Cincinnati, Ohio

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