A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
Cancer-Related Syndrome
Leukemia
18 Years and older, Male and Female
NX-5948-301 (primary)
NCI-2023-01623
Summary
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the
safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.
Objectives
Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-5948 in adult
patients with relapsed/refractory (R/R) B cell malignancies who have received at least 2
prior lines of therapy, or at least 1 prior line of therapy for Primary Central Nervous
System Lymphoma (PCNSL), and for whom no other therapies are known to provide clinical
benefit. Indications include: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma
(SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Waldenstrom
Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), or Primary
Central Nervous System Lymphoma (PCNSL).
Phase 1b will investigate the efficacy of NX-5948 at the dose(s) selected in Phase 1a in up
to 7 expansion arms of patients with histologically confirmed R/R B-cell malignancy
indications who have received the specified prior therapies based on indication:
- CLL or SLL (two dose levels will be investigated for CLL/SLL)
- MCL
- MZL
- WM
- DLBCL
- FL
- PCNSL/SCNSL
Eligibility
- Age =18 years
- Patients in Phase 1a (Dose Escalation) must have histologically confirmed R/R CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.
- Patients in Phase 1a must meet the following: o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy
- Patients in Phase 1b (Cohort Expansion) must have 1 of the following histologically documented R/R B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies based on indication: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL/SCNSL.
- Measurable disease per response criteria specific to the malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).
- Adequate organ and bone marrow function
Treatment Sites in Georgia
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