A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a Bcell Lymphoma-2 Inhibitor (BCL-2i) (DAYBreak CLL-201)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nurix Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

23 Oct 2025 → ongoing

Decision date (initial)

2025-10-02

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Nurix Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic, Efficacy

To evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, a ncBTKi, and a BCL-2i in accordance with iwCLL guidelines (Hallek 2018)

Secondary objectives 4

1. To further evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, a ncBTKi and a BCL2i in accordance with the 2018 iwCLL guidelines (Hallek 2018)
2. To evaluate the safety and tolerability of NX-5948
3. To characterize the PK of NX-5948
4. To evaluate the effect of NX-5948 on quality of life

Conditions and MedDRA coding

Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age: ≥ 18 years
2. Confirmed diagnosis of CLL/SLL that meets iwCLL criteria diagnosis and systemic treatment (Hallek 2018)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Prior exposure to a cBTKI, a ncBTKi, and a BCL2i either in separate lines of treatment or in combination
5. Measurable disease by computed tomography (CT) per iwCLL
6. Adequate organ and bone marrow function

Exclusion criteria 6

1. Known or suspected prolymphocytic leukemia or Richter’s transformation at any time preceding enrolment. Note: In cases of clinical suspicion of Richter's Transformation, the treating physician may determine if histopathological evaluation should be performed and results reviewed by the treating physician to rule out transformation prior to enrollment.
2. Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug.
3. Radiotherapy within 2 weeks of the first dose of study treatment
4. Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days prior to initiation of study drug excepting those used as prophylaxis for radio diagnostic contrast
5. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug
6. Previously treated with a BTK degrader

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR (without PR-L) as assessed by IRC

Secondary endpoints 11

1. ORR with PR-L as assessed by IRC
2. DOR as assessed by IRC and by investigator
3. PFS as assessed by IRC and by investigator
4. Complete response rate as assessed by IRC and by investigator
5. TTR as assessed by IRC and by investigator
6. OS
7. Including, but not limited to, incidence and severity of TEAEs, SAEs and TEAEs leading to study drug discontinuation
8. Changes from baseline in laboratory parameters and vital signs
9. Summary measures of PK trough concentrations
10. ORR (with and without PR-L) as assessed by investigator
11. PROs measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nurix Therapeutics Inc.

Sponsor organisation

Nurix Therapeutics Inc.

Address

1700 Owens Street Suite 205

City

San Francisco

Postcode

94158-0006

Country

United States

Scientific contact point

Organisation

Nurix Therapeutics Inc.

Contact name

Paula O'Connor

Public contact point

Organisation

Nurix Therapeutics Inc.

Contact name

Paula O'Connor

Third parties 11

Locations

4 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 43 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications