Chronic Lymphocytic Leukemia Clinical Trial

A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies

Summary

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.

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Full Description

Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM) and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of NX-2127 at the dose selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM):

Chronic Lymphocytic Leukemia (leukemia-cll/" >CLL) or Small Lymphocytic Lymphoma (SLL) with no BTK C481 mutation
BTK C481 mutation-positive CLL/SLL
Mantle Cell Lymphoma (MCL)
Follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL)
Diffuse Large B-cell Lymphoma (DLBCL) or Waldenstrom Macroglobulinemia (WM)

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Eligibility Criteria

Inclusion Criteria:

Patients must be ≥ 18 years of age
Patients must have measurable disease per disease-specific response criteria
Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, or Lugano Classification of Lymphoma response criteria)
Patients with transformed lymphoma are eligible for the study with the exception of those who have prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function, in the absence of growth factors
Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol

Inclusion Criteria for Patients in Phase 1a:

Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL(grade 1 - 3b), or DLBCL
Received at least 2 prior systemic therapies (or 1 prior therapy for patients with WM) and have no other therapies known to provide clinical benefit
Must require systemic therapy

Inclusion Criteria for Patients in Phase 1b:

Must have one of the following histologically documented R/R B-cell malignancies:

CLL/SLL with no BTK C481 mutation whose disease has failed treatment with a BTKi;
BTK C481 mutation-positive CLL/SLL whose disease has failed treatment with a BTKi;
MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen
FL (grade 1 - 3b) or MZL whose disease has failed treatment with anti-CD20 mAb-based regimen;
DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and an anthracycline (either progressed post stem cell transplant or transplant-ineligible) or WM whose disease has failed treatment with BTKi

Exclusion Criteria:

History of CNS lymphoma/leukemia in remission for less than 2 years
Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
History of known/suspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)
Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug
Bleeding diathesis, or other known risk for acute blood loss
Patients requiring ongoing treatment with chronic, therapeutic anticoagulation with warfarin or patients treated with dual anti-platelet therapy and vitamin K antagonists
Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)
Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, hypothyroidism with adequate replacement therapy, hypopituitarism with adequate replacement therapy, peripheral neuropathy or hematologic parameters meeting inclusion criteria).
Active known second malignancy
Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 > 350/mm3 and undetectable viral load) are eligible.
Current active liver disease from any cause
Active viral reactivation (e.g., CMV or EBV)
Use of systemic corticosteroids (> 20 mg/day prednisone or equivalent) within 15 days, or other immunosuppressive drugs within 30 days, prior to start of the study
Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug
Patient is taking strong or moderate cytochrome P450 3A (CYP3A) inducers or inhibitors or inhibitors of P-glycoprotein

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT04830137

Recruitment Status:

Recruiting

Sponsor:

Nurix Therapeutics, Inc.

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There are 12 Locations for this study

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City of Hope
Duarte California, 91010, United States
University of California Irvine
Orange California, 92868, United States
University of California San Francisco Medical Center
San Francisco California, 94143, United States
Sarah Cannon Research Institute at Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Sarasota Florida, 34203, United States
National Institutes of Health Clinical Center
Bethesda Maryland, 20814, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, United States
OSU Wexner Medical Center
Columbus Ohio, 43210, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT04830137

Recruitment Status:

Recruiting

Sponsor:


Nurix Therapeutics, Inc.

How clear is this clinincal trial information?

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