Ireland
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Recruiting Phase 1

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

NCT04830137 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2021-05-05
Last updated
2026-03-20

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Waldenstrom Macroglobulinemia (WM)Mantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)Follicular Lymphoma (FL)Diffuse Large B-cell Lymphoma (DLBCL)Primary Central Nervous System Lymphoma (PCNSL)

Investigational drug(s) / intervention(s)

NX-2127

NX-2127: Oral NX-2127

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria) * Patients with transformed lymphoma are eligible for the study with the exception of those detailed in Exclusion Criteria #1: 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 (non-PCNSL indications) or 0 - 2 (PCNSL patients) * Adequate organ and bone marrow function * 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, DLBCL, or PCNSL * Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) 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 whose disease has failed treatment with a BTKi; * MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen * FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi * PCNSL whose disease failed at least 1 prior line of treatment * DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen, or another/ palliative regimen (either progressed post stem cell transplant or transplant-ineligible) Exclusion Criteria: * 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 warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug * 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. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible * 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 exceeding 20 mg/day prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg/day prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start. * Use of non-steroidal 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 * Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days

Primary outcome measure(s)

  • Number of Participants with Protocol Specified Dose-Limiting Toxicities — Up to 24 months
    Phase 1a
  • To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127 — Up to 24 months
    Phase 1a
  • To evaluate the clinical activity of NX-2127 at the recommended Phase 1b dosage(s) based on overall response rate (ORR) as assessed by the Investigator — Up to 4 years
    Phase 1b
  • Number of Participants with Adverse Events and Clinical Laboratory Abnormalities — Up to 5 years
    Phase 1a/1b

Trial sites (16)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
University of California Irvine Orange California Completed
University of California San Francisco Medical Center San Francisco California Completed
Sarah Cannon Research Institute at Colorado Blood Cancer Institute Denver Colorado Recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach Florida Completed
Sarah Cannon Research Institute at Florida Cancer Specialists Sarasota Florida Completed
The University of Chicago Medical Center Chicago Illinois Recruiting
National Institutes of Health Clinical Center Bethesda Maryland Recruiting
Memorial Sloan Kettering Cancer Center New York New York Completed
University of Cincinnati Medical Center Cincinnati Ohio Completed
OSU Wexner Medical Center Columbus Ohio Completed
Tennessee Oncology Nashville Tennessee Recruiting
Baylor University Medical Center Dallas Texas Completed
MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting
Swedish Cancer Institute Seattle Washington Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04830137 on ClinicalTrials.gov ↗ ← All trials in the USA