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Virus Therapy

NX-2127 for B-cell Malignancies

Phase 1

Recruiting

Research Sponsored by Nurix Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)

Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL(grade 1 - 3b), DLBCL, or PCNSL

Must not have

Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia

Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

Adults with certain types of blood cancer who've had at least two prior treatments (or one for specific conditions) can join this trial. They must be over 18, not pregnant, and have a good performance status. People with uncontrolled diseases, recent major surgery or radiation, active infections like HIV or hepatitis, or autoimmune diseases aren't eligible.

What is being tested?

The study is testing NX-2127's safety and effectiveness against advanced B-cell malignancies. It's an early-stage trial where all participants receive the same experimental drug to see how well it works and what side effects it may cause.

What are the potential side effects?

Since NX-2127 is in early testing stages, potential side effects are being investigated but could include typical reactions to cancer drugs such as nausea, fatigue, allergic reactions, blood disorders and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is a confirmed type of blood or lymphatic system cancer.

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I've had at least 2 treatments for my condition, or 1 if I have WM/PCNSL, and no other treatment options are known to help.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active autoimmune condition affecting my blood.

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I haven't had radiotherapy in the last 2 weeks, except for palliative care.

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I have an active liver condition.

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I cannot swallow pills or have a condition that affects drug absorption.

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I have a condition that increases my risk of bleeding.

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I am currently on warfarin or similar blood thinners and started within the last week.

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I have another type of cancer that is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events and Clinical Laboratory Abnormalities

Number of Participants with Protocol Specified Dose-Limiting Toxicities

To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127

+1 more

Secondary study objectives

Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator

Duration of response (DOR) as assessed by the Investigator

Overall survival (OS) as assessed by the Investigator

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Group I: Phase 1b Dose Optimization Stage 2 in PCNSL (Randomized to Dose A or Dose B)Experimental Treatment1 Intervention

PCNSL patients whose disease has failed at least 1 prior line of treatment

Group II: Phase 1b Dose Optimization Stage 2 in MCL (Randomized to Dose A or Dose B)Experimental Treatment1 Intervention

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

Group III: Phase 1b Dose Optimization Stage 2 in FL, MZL or WM (Randomized to Dose A or Dose B)Experimental Treatment1 Intervention

FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor

Group IV: Phase 1b Dose Optimization Stage 2 in DLBCL (Randomized to Dose A or Dose B)Experimental Treatment1 Intervention

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

Group V: Phase 1b Dose Optimization Stage 2 in CLL or SLL (Randomized to Dose A or Dose B)Experimental Treatment1 Intervention

CLL/SLL patients whose disease has failed treatment with a BTK inhibitor

Group VI: Phase 1b Dose Optimization Stage 1 in PCNSL (Dose A)Experimental Treatment1 Intervention

PCNSL patients whose disease has failed at least 1 prior line of treatment

Group VII: Phase 1b Dose Optimization Stage 1 in MCL (Dose A)Experimental Treatment1 Intervention

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

Group VIII: Phase 1b Dose Optimization Stage 1 in FL, MZL or WM (Dose A)Experimental Treatment1 Intervention

FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor

Group IX: Phase 1b Dose Optimization Stage 1 in DLBCL (Dose A)Experimental Treatment1 Intervention

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

Group X: Phase 1b Dose Optimization Stage 1 in CLL or SLL (Dose A)Experimental Treatment1 Intervention

CLL/SLL patients whose disease has failed treatment with a BTK inhibitor

Group XI: Phase 1a Dose EscalationExperimental Treatment1 Intervention

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

0 / 11Eligibility criteria met