A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies (NCT04830137) | Clinical Trial Compass
RecruitingPhase 1
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
United States248 participantsStarted 2021-05-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 B…
What they're measuring
1
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Timeframe: Up to 24 months
2
To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127
Timeframe: Up to 24 months
3
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
Timeframe: Up to 4 years
4
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities