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Virus Therapy
NX-5948 for B-cell Cancer
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
Radiographically measurable disease per response criteria specific to the malignancy. Target lymph nodes must be > 1.5 cm and extranodal lesions must be ≥ 1.0 cm in longest diameter
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a new drug for advanced B-cell cancer. Scientists will look at safety and effectiveness.
Who is the study for?
Adults over 18 with certain advanced B-cell malignancies, measurable disease, and in good physical condition (ECOG 0-1) can join. They must have tried at least two prior treatments without success. Excluded are those recently treated with chemotherapy, monoclonal antibodies, small molecules or immunosuppressives; have heart issues, uncontrolled blood pressure or bleeding disorders; received CAR T-cell therapy or stem cell transplant too recently.Check my eligibility
What is being tested?
The trial is testing NX-5948's safety and effectiveness against various B-cell cancers. It's a first-in-human study that includes an initial phase to find the right dose and a second phase to see how well it works on specific cancer types.See study design
What are the potential side effects?
Potential side effects of NX-5948 aren't detailed here as this is a first-in-human trial. However, common side effects for new cancer drugs may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on scans, with visible tumors.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with protocol specified dose-limiting toxicities
Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
+1 moreSecondary outcome measures
Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator
Duration of response (DOR) as assessed by the Investigator
Pharmacodynamic (PD) profile of NX-5948: Changes from baseline of BTK levels in B-cells
+3 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Phase 1b in WMExperimental Treatment1 Intervention
WM with prior exposure to a BTKi and an additional line of therapy
Group II: Phase 1b in PCNSL/SCNSLExperimental Treatment1 Intervention
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
Group III: Phase 1b in MZLExperimental Treatment1 Intervention
MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy regimen and an additional line of therapy
Group IV: Phase 1b in MCLExperimental Treatment1 Intervention
MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody (mAb)-based chemo-immunotherapy regimen
Group V: Phase 1b in FLExperimental Treatment1 Intervention
FL (grade 1-3a) with prior exposure to an anti-CD20 mAb-based chemoimmunotherapy regimen and an additional line of therapy
Group VI: Phase 1b in DLBCLExperimental Treatment1 Intervention
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
Group VII: Phase 1b in CLL or SLLExperimental Treatment1 Intervention
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.
Group VIII: Phase 1a Dose EscalationExperimental Treatment1 Intervention
Multiple dose levels of NX-5948 to be evaluated; determination of Maximum Tolerated Dose/Phase 1b recommended dose(s)
Find a Location
Who is running the clinical trial?
Nurix Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
555 Total Patients Enrolled
Su Young Kim, MD, PhDStudy DirectorNurix Therapeutics, Inc.
Paula O'Connor, MDStudy DirectorNurix Therapeutics, Inc.
3 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immunosuppressive drugs, except for corticosteroids, in the last 30 days.I have a confirmed diagnosis of a specific type of blood cancer.I haven't had CAR T-cell therapy in the last 100 days (30 days for Phase 1b) or I have evidence of B-cell recovery after such therapy.I haven't taken small molecule therapy in the last 4 weeks or 5 half-lives.I do not have severe heart issues like uncontrolled irregular heartbeat or advanced heart failure.I have a condition that increases my risk of bleeding.My cancer can be measured on scans, with visible tumors.I haven't had chemotherapy in the last 4 weeks.I had a stem cell transplant less than 100 days ago.I can care for myself and perform daily activities.I have a specific type of blood cancer and it has not improved after two treatments.I do not have serious heart conditions or uncontrolled high blood pressure.I am 18 years old or older.My organs and bone marrow are working well.I have not had serious bleeding in the last 28 days.I haven't had monoclonal antibody therapy in the last 4 weeks.I do not have uncontrolled autoimmune blood disorders.I haven't had radiotherapy for cancer treatment within the last 2 weeks.I have had a recent heart attack, unstable chest pain, or a procedure to open my heart's arteries.I have had a clotting event, stroke, or bleeding in the brain.I am not using high doses of steroids, or if I am, it's stable and within limits.I have had at least 2 treatments for my condition and no other known treatments can help.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b in DLBCL
- Group 2: Phase 1b in CLL or SLL
- Group 3: Phase 1b in WM
- Group 4: Phase 1b in MCL
- Group 5: Phase 1b in PCNSL/SCNSL
- Group 6: Phase 1b in FL
- Group 7: Phase 1b in MZL
- Group 8: Phase 1a Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still open for this clinical trial?
"Confirmed, clinicaltrials.gov hosts the most recent information on this active medical trial which was first posted in April of 2022 and updated last month."
Answered by AI
How many individuals is this research endeavor examining?
"Affirmative. The records hosted on clinicaltrials.gov points to this study actively seeking participants, which was first posted in April 13th 2022 and recently updated in May 8th 2023. A total of 130 patients are needed across 10 different medical centres."
Answered by AI
Has the United States Food and Drug Administration sanctioned Phase 1b for primary central nervous system lymphoma?
"Taking into consideration the limited clinical data available, we have assigned Phase 1b in PCNSL a safety score of 1."
Answered by AI
Are there any facilities in North America that have undertaken this clinical investigation?
"This study is now being conducted in 10 different cities, including London, Glasgow and Plymouth. Prospective participants should choose the nearest trial site to reduce any potential travel related burdens."
Answered by AI
What goals is this medical trial hoping to realize?
"The primary outcome of the study, to be monitored over 10 months, is the number of individuals with protocol-specified dose limiting toxicities. Other assessed results include complete response rate/CR with incomplete marrow recovery (Phase 1a/1b), time to next therapy (Phase 1a/1b) and duration of response as judged by an investigator (Phase 1a/1b)."
Answered by AI
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