Clinical Trials in the USA / NCT04830137
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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