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), Primary Central Nervous System Lymphoma (PCNSL) or any of the above indications
with disease in the central nervous system or Secondary Central Nervous System Lymphoma
(SCNSL).
Phase 1b Part 1, called safety expansion, investigates the safety and anti-tumor activity
of NX-5948 at the dose(s) selected in Phase 1a in up to 17 expansion cohorts of patients
with histologically confirmed B-cell malignancy indications who have received specified
prior therapies based on indication:
- CLL or SLL (patients may be randomized to one of two dose levels investigated for
CLL/SLL until an optimal dose is selected)
- MCL
- MZL
- WM
- DLBCL
- FL
- PCNSL/SCNSL
Phase 1b Part 2, called cohort expansion, will further investigate the anti-tumor
activity of NX-5948 at the dose(s) selected in Phase 1b par 1 in one additional expansion
arm of CLL/SLL patients.
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 available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy
- Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and/or molecular features based on details described for each cohort: 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 Key
Treatment Sites in Georgia
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