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Virus Therapy
NX-2127 for B-cell Malignancies
Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
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 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 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
Overall survival (OS) as assessed by the Investigator
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion in MCLExperimental Treatment1 Intervention
MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Group II: Phase 1b Dose Expansion in FL, MZL or PCNSLExperimental Treatment1 Intervention
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
Group III: Phase 1b Dose Expansion in DLBCL or WMExperimental Treatment1 Intervention
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
Group IV: Phase 1b Dose Expansion in CLL or SLL with no BTK C481 mutationExperimental Treatment1 Intervention
CLL/SLL patients with no BTK C481 mutation whose disease has failed treatment with a BTK inhibitor
Group V: Phase 1b Dose Expansion in BTK C481 mutation-positive CLL/SLLExperimental Treatment1 Intervention
BTK C481 mutation-positive CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Group VI: Phase 1a Dose EscalationExperimental Treatment1 Intervention
Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
Find a Location
Who is running the clinical trial?
Nurix Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
687 Total Patients Enrolled
Paula O'Connor, MDStudy DirectorNurix Therapeutics, Inc.
3 Previous Clinical Trials
644 Total Patients Enrolled
Robert J Brown, MDStudy DirectorNurix Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active autoimmune condition affecting my blood.I haven't taken strong medication affecting liver enzymes or certain drug transporters in the last 2 weeks.I haven't had radiotherapy in the last 2 weeks, except for palliative care.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is a confirmed type of blood or lymphatic system cancer.My CNS lymphoma/leukemia has been in remission for less than 2 years, or I have disease outside the CNS.I had major surgery within the last 4 weeks.I have an active liver condition.I cannot swallow pills or have a condition that affects drug absorption.My B-cell cancer has not responded to specific previous treatments.I have transformed lymphoma but not with specific types or mutations.I have a condition that increases my risk of bleeding.My organs and bone marrow are working well.My slow-growing lymphoma needs treatment according to specific medical guidelines.I haven't taken more than 20 mg/day of steroids for conditions other than PCNSL, or more than 40 mg/day for PCNSL, in the last 15 days.I am currently on warfarin or similar blood thinners and started within the last week.Side effects from my past cancer treatments have mostly gone away or are mild.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.You currently have a viral infection that is active, like CMV or EBV.I am 18 years old or older.I haven't taken any non-steroidal immunosuppressive drugs in the last 30 days.Patients must have a way to measure their disease based on specific criteria for that disease.I haven't had a heart attack or uncontrolled heart issues in the last 6 months.I need treatment that affects my whole body.I have HIV but it is well-controlled.I have an autoimmune disease, but it's either alopecia, vitiligo, resolved childhood atopic dermatitis, or thyroid issues under control.I have another type of cancer that is currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Dose Expansion in MCL
- Group 2: Phase 1b Dose Expansion in BTK C481 mutation-positive CLL/SLL
- Group 3: Phase 1b Dose Expansion in DLBCL or WM
- Group 4: Phase 1b Dose Expansion in FL, MZL or PCNSL
- Group 5: Phase 1a Dose Escalation
- Group 6: Phase 1b Dose Expansion in CLL or SLL with no BTK C481 mutation
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.
At which sites is the experiment taking place?
"For optimal convenience, enrollees are encouraged to visit the closest of 12 participating sites which encompass cities such as Nashville, Orange and Sarasota."
Answered by AI
Is there still opportunity for patients to enroll in this experiment?
"As indicated on clinicaltrials.gov, this experiment is currently recruiting volunteers, with the first post date being May 5th 2021 and last edit taking place November 15th 2022."
Answered by AI
What is the present enrollment size of this medical experiment?
"To satisfy the requirements of this clinical trial, a total of 130 participants will be selected - based on eligibility criteria. These individuals can enrol from Sarah Cannon Research Institute at Tennessee Oncology in Nashville and University of California Irvine in Orange."
Answered by AI
What would be the ultimate outcome of this experiment?
"This 10-month medical trial will assess NX2127's effectiveness based on overall response rate, maximum serum concentration, duration of response and complete remission with incomplete marrow recovery. The investigators are expecting to glean a great amount of valuable data from the study."
Answered by AI
What potential risks come with the use of NX-2127?
"As this is an early-stage clinical trial, the safety profile of NX-2127 has been rated a 1 due to limited data found in Phase 1 trials."
Answered by AI
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