A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Leukemia	NCT ID:	NCT05131022
Trial Phases:	Phase I	Protocol IDs:	NX-5948-301 (primary) NCI-2023-01623
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Nurix Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05131022

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, will investigate the safety and anti-tumor
activity of NX-5948 at the dose(s) selected in Phase 1a in up to 13 expansion cohorts of
patients with histologically confirmed R/R B-cell malignancy indications who have
received the specified prior therapies based on indication:

- CLL or SLL (patients may be randomized to one of two dose levels investigated for
CLL/SLL)

- 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.