Last reviewed · How we verify
NCT05602363
A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Phase 1 trial testing Docirbrutinib in B-cell Malignancy in 120 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | Carna Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 August 2023 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 13 locations across United States |
Drugs / interventions tested
- Docirbrutinib — full drug profile →
Conditions studied
- B-cell Malignancy — all drugs for B-cell Malignancy →
- Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
- Small Lymphocytic Lymphoma — all drugs for Small Lymphocytic Lymphoma →
- Waldenstrom Macroglobulinemia — all drugs for Waldenstrom Macroglobulinemia →
Sponsor
Carna Biosciences, Inc. — full company profile →
Who can join
18 and older, any sex, with B-cell Malignancy or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Time frame: Up to 24 cycles (1 cycle = 28 days)
Dose escalation -
Overall response rate (ORR) as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Dose expansion
Sponsor's own description
This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel BTK inhibitors and degraders for relapsed/refractory CLL/SLL: latest updates from ASH 2025 annual meeting
Sharma P, Jiang H, Liu D. · · 2026 -
Docirbrutinib is a pan-mutant BTK inhibitor and inhibits B-cell receptor signaling in chronic lymphocytic leukemia cells in preclinical and early clinical investigations.
Timofeeva N, Herrera B, Fujiwara H, Asami T, et al · · 2026 · PMID 42098067 · DOI 10.1038/s41408-026-01509-8 -
EHA2024 Hybrid Congress
· 2024
Verify or expand the search:
- PubMed search for NCT05602363
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for B-cell Malignancy
Currently open trials in the same condition.
- NCT06634589 — A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relap · Phase 1, PHASE2 · recruiting
- NCT05294731 — Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Deg · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05602363 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Carna Biosciences, Inc.
- Last refreshed: 9 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05602363.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing