Neoplasms

Blood and Lymph Conditions

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Heart and Blood Diseases

Rare Diseases

Lymphoma

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Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

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Blood Protein Disorders

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Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

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B-cell Lymphoma

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Diffuse Large B-Cell Lymphoma

Primary Central Nervous System Lymphoma

All Drugs and Chemicals

Amino Acids

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Tyrosine Kinase Inhibitors

Tyrosine

Multiple dose levels of NX-5948 to be evaluated; determination of Maximum Tolerated Dose/Phase 1b recommended dose(s)

CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor, unless previously deemed ineligible for those therapies. Patients enrolled in CLL/SLL arm will be randomized to one of two dose levels. This is the only randomization component in the trial.

MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody (mAb)-based chemo-immunotherapy regimen

MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy regimen and an additional line of therapy

PCNSL patients who have progressed or had no response to at least 2 prior lines of therapy, or SCNSL patients meeting criteria for non-CLL/SLL arms above with secondary CNS involvement of lymphoma

WM with prior exposure to a BTKi and an additional line of therapy

DLBCL with prior exposure to an anthracycline (unless previously deemed ineligible to receive), an anti-CD20 mAb-based chemoimmunotherapy regimen, and an additional line of therapy

FL (grade 1-3a) with prior exposure to an anti-CD20 mAb-based chemoimmunotherapy regimen and an additional line of therapy

NX-5948

Patient Outreach

Ana Ayala

Paula O'Connor, MD

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.

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

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

A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies

Phase 1a/1b - Sampling following the first dose, pre- and post-dose at selected cycles and at the end of treatment

Phase 1a/1b - Sampling at screening, following the first dose, pre and post-dose at selected cycles and at the end of treatment

Nurix Therapeutics, Inc.

Antineoplastic Agents

Lenalidomide

Pomalidomide

Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose

CLL/SLL patients with no BTK C481 mutation whose disease has failed treatment with a BTK inhibitor

BTK C481 mutation-positive CLL/SLL patients whose disease has failed treatment with a BTK inhibitor

MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen

FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or PCNSL whose disease has failed at least 1 prior line of treatment

DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either an anthracycline, an anti-CD19-based regimen, or another/palliative regimen; or WM patients whose disease has failed treatment with a BTK inhibitor

NX-2127

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.

Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of NX-2127 at the dosage(s) selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL):

* Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with no BTK C481 mutation
* BTK C481 mutation-positive CLL/SLL
* Mantle Cell Lymphoma (MCL)
* Follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL); or Primary Central Nervous System Lymphoma (PCNSL)
* Diffuse Large B-cell Lymphoma (DLBCL) or Waldenstrom Macroglobulinemia (WM)

A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies

A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies	NCT05131022	Chronic Lymphoc... Small Lymphocyt... Diffuse Large B... Follicular Lymp... Mantle Cell Lym... Marginal Zone L... Waldenstrom Mac... Primary Central...	NX-5948	18 Years -	Nurix Therapeutics, Inc.
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies	NCT04830137	Chronic Lymphoc... Small Lymphocyt... Waldenstrom Mac... Mantle Cell Lym... Marginal Zone L... Follicular Lymp... Diffuse Large B... Primary Central...	NX-2127	18 Years -	Nurix Therapeutics, Inc.

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