B-Cell Malignancies Clinical Trials Recruiting Now: Novel BTK Degrader BGB-16673 (CaDAnCe-101) Study Across 31 US Sites
A first-in-class BTK degrader (BGB-16673) is recruiting across 31 US sites for relapsed/refractory B-cell malignancies including CLL, MCL, WM, MZL, FL, and DLBCL. The CaDAnCe-101 trial (NCT05006716) offers a novel mechanism to overcome covalent BTK inhibitor resistance.
B-Cell Malignancies Clinical Trials Recruiting Now: Novel BTK Degrader BGB-16673 (CaDAnCe-101) Study Across 31 US Sites
B-cell malignancies — including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström macroglobulinemia (WM), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL) — affect over 100,000 Americans annually. For patients whose disease has relapsed or is refractory to standard therapies, Bruton tyrosine kinase (BTK) inhibitors like ibrutinib, acalabrutinib, and zanubrutinib have transformed outcomes. However, resistance inevitably develops through BTK mutations (especially C481S) or alternative pathway activation, leaving patients in need of next-generation options.
A first-in-class non-covalent BTK degrader, BGB-16673, is now being evaluated in a large Phase 1/2 trial (CaDAnCe-101, NCT05006716) across 31 actively recruiting US sites. Unlike covalent BTK inhibitors that irreversibly bind BTK's C481 residue, BGB-16673 promotes targeted protein degradation, potentially overcoming covalent BTK inhibitor resistance while preserving activity against wild-type and C481S-mutant BTK.
Actively Recruiting Trial: BGB-16673 in Relapsed/Refractory B-Cell Malignancies (CaDAnCe-101, NCT05006716)
NCT ID: NCT05006716
Sponsor: BeiGene
Study Name: CaDAnCe-101 — A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Phase: 1/2
Status: RECRUITING
Estimated Enrollment: ~480 participants
Study Design: Open-label, multicenter, dose-escalation (Part 1) followed by cohort expansion (Part 2)
Intervention: BGB-16673 orally, once daily; dose levels being evaluated in Phase 1, recommended dose(s) expanded in Phase 2
Primary Outcomes: Safety/tolerability (dose-limiting toxicities, adverse events), pharmacokinetics, recommended Phase 2 dose (RP2D); efficacy (overall response rate per Lugano 2014 / iwCLL 2018)
Key Eligibility: Confirmed diagnosis of one of: MZL, FL (Grades 1, 2, 3a), MCL, CLL/SLL, WM, R/R DLBCL, or Richter's transformation; relapsed/refractory to or intolerant of standard therapies; measurable disease; ECOG 0–1; adequate organ function. Participants who are BTK-inhibitor naive may enroll in specific expansion cohorts.
Last Verified: 2026-07-24 (ClinicalTrials.gov)
Key US Recruiting Locations (31 Sites)
| Site | City, State | Facility | Status |
|---|---|---|---|
| Dana-Farber Cancer Institute | Boston, MA | RECRUITING | |
| Memorial Sloan Kettering Cancer Center | New York, NY | RECRUITING | |
| Weill Cornell Medicine / NewYork-Presbyterian | New York, NY | RECRUITING | |
| Columbia University Medical Center | New York, NY | RECRUITING | |
| MD Anderson Cancer Center | Houston, TX | RECRUITING | |
| Mayo Clinic Rochester | Rochester, MN | RECRUITING | |
| Roswell Park Comprehensive Cancer Center | Buffalo, NY | RECRUITING | |
| City of Hope / Karmanos | Detroit, MI | RECRUITING | |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill, NC | RECRUITING | |
| VCU Massey Cancer Center | Richmond, VA | RECRUITING | |
| Fred Hutchinson Cancer Research Center | Seattle, WA | RECRUITING | |
| University of Iowa / Holden Comprehensive Cancer Center | Iowa City, IA | RECRUITING | |
| Norton Cancer Institute | Louisville, KY | ACTIVE_NOT_RECRUITING | |
| ...and 21 additional sites across AZ, CA, FL, GA, IL, KY, LA, MD, NV, NJ, OH, OK, RI, SC, TN, UT, WI |
Full site list with contact details: ClinicalTrials.gov NCT05006716 Locations
How BGB-16673 Differs from Current BTK Inhibitors
| Feature | Covalent BTK Inhibitors (ibrutinib, acalabrutinib, zanubrutinib) | BGB-16673 (Non-covalent BTK Degrader) |
|---|---|---|
| Binding Mechanism | Irreversible covalent bond to C481 residue | Reversible non-covalent binding + targeted protein degradation |
| Activity vs. C481S Mutant | Lost (primary resistance mechanism) | Retained — degrades both WT and C481S BTK |
| Resistance Profile | C481S mutations, PLCG2 mutations | Designed to overcome covalent BTKi resistance |
| Dosing | Continuous daily until progression/toxicity | Once daily; RP2D being defined in Phase 1 |
| Clinical Stage | Approved (multiple indications) | Phase 1/2 (investigational) |
| Key Safety Concerns | Atrial fibrillation, bleeding, hypertension, infections | Under investigation; BTK degradation may offer differentiated profile |
Data sources: FDA prescribing information for approved BTK inhibitors; NCT05006716 protocol; BeiGene ASCO 2024/2025 abstracts.
Broader B-Cell Malignancy Trial Landscape on Corterve
Beyond CaDAnCe-101, Corterve lists 11 actively recruiting US trials for B-cell malignancies (leukemias and lymphomas) as of July 2026, including:
- NCT04609046 — Lenalidomide + Nivolumab for Primary CNS Lymphoma (NCI-sponsored, 55 US sites)
- NCT05947851 — Nemtabrutinib + Venetoclax vs. Venetoclax + Rituximab in CLL/SLL (6 US sites)
- NCT07116616 — mRNA-2808 in Relapsed/Refractory Multiple Myeloma (10 US sites)
- NCT05006716 — BGB-16673 CaDAnCe-101 (31 US sites, featured above)
Explore all recruiting B-cell malignancy trials: /trials?condition=b-cell+malignancies
What This Means for Patients
If you have a relapsed or refractory B-cell malignancy (CLL/SLL, MCL, WM, MZL, FL, DLBCL, or Richter's transformation) and have exhausted or are intolerant to standard therapies — including covalent BTK inhibitors — NCT05006716 may offer a novel mechanistic option. The trial is enrolling at major academic centers nationwide, and specific expansion cohorts welcome BTK-inhibitor-naive patients.
Next steps:
- Review eligibility — Confirm your diagnosis, prior treatments, and current health status match the criteria.
- Find a nearby site — Use the Corterve trial search or ClinicalTrials.gov location list to identify the closest recruiting center.
- Discuss with your hematologist/oncologist — Share the NCT ID (NCT05006716) and ask whether referral is appropriate.
- Contact the site — Reach out to the study coordinator listed for your preferred location.
Important Disclaimers
This article is for informational purposes only and does not constitute medical advice. Corterve is a clinical trial matching platform, not a healthcare provider. We do not guarantee eligibility, enrollment, treatment efficacy, or outcomes. Clinical trial recruitment status changes frequently; site-level availability may differ from public listings. All eligibility determinations are made solely by the study team at each site. Always discuss clinical trial participation with your treating hematologist or oncologist before making any decisions.
Sources: ClinicalTrials.gov NCT05006716 (accessed 2026-07-24); NCT04609046; BeiGene investor presentations (ASCO 2024/2025); FDA prescribing information for ibrutinib, acalabrutinib, zanubrutinib; NCCN Guidelines for B-Cell Lymphomas and CLL/SLL (v2026).