RecruitingPhase 1

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

United States, France, Italy572 participantsStarted 2022-04-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).
. Prior systemic chemotherapy within 2 weeks of planned start of study drug.
. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.
. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.
. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.
. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).
. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL/SCNSL: no greater than 40 mg/day prednisone, or equivalent. Patients with PCNSL/SCNSL using greater than 20 mg/day prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg/day prednisone or equivalent.
. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since NX-5948 is in Phase 1 and the trial is still figuring out the safest dose, what does that mean for my personal risk — and how does that compare to the risks of standard treatments I might still be eligible for?
2The trial is specifically measuring dose-limiting toxicities and serious adverse events — given my overall health and the specific type of B-cell cancer I have, do you think I'm in a position to safely handle the unknowns that come with a first-in-human dose-finding study like this?
3My cancer type is one of several being studied here — do you know whether there's a specific dose expansion group for my diagnosis, like CLL/SLL, and would that affect how my response to the drug would be tracked and evaluated?
4This trial is for people whose cancer has come back or stopped responding to prior treatments — given my treatment history, do you think I've exhausted enough options that a Phase 1 trial makes sense now, or are there other approved therapies worth trying first?
5If I enrolled and had to stop the study drug due to a serious side effect, what would my treatment options look like at that point, and would participating in this trial limit what I could access next?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with protocol specified dose-limiting toxicities

Timeframe: Up to 24 months

To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)

Timeframe: Up to 24 months

To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by Investigator

Timeframe: Up to 3 years

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

Timeframe: Up to 6 years

To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by Investigator

Timeframe: Up to 3 years

Trial details

NCT IDNCT05131022

SponsorNurix Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Additional Site Contact Information

+1 (415) 417-3418 clinicaltrials@nurixtx.com

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia (CLL) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).
. Prior systemic chemotherapy within 2 weeks of planned start of study drug.
. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.
. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.
. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.
. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).
. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL/SCNSL: no greater than 40 mg/day prednisone, or equivalent. Patients with PCNSL/SCNSL using greater than 20 mg/day prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg/day prednisone or equivalent.
. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug

What they're measuring

Number of participants with protocol specified dose-limiting toxicities

Timeframe: Up to 24 months

To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)

Timeframe: Up to 24 months

To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by Investigator

Timeframe: Up to 3 years

Timeframe: Up to 6 years

To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by Investigator

Timeframe: Up to 3 years