Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT06590961
Eligibility Criteria:
Key Inclusion Criteria
* Capable of giving signed informed consent
* Age ≥18 years
* ECOG performance status ≤2.
* Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
* Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
* Adequate organ and bone marrow function
Key Exclusion Criteria
* For subjects with lymphoma:
* Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
* Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
* Unconjugated monoclonal antibody therapies \<6 weeks before the first dose of study treatment.
* Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
* Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
* Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
* History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
* Any immunotherapy within 4 weeks of first dose of study drug.
* The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \<5 times the t1/2 of the previously administered agent(s).
* Previously exposed to BTK degradation therapy
* Malignant disease, other than that being treated in this study.
* Radiotherapy within 2 weeks of the first dose of study treatment
* Known hypersensitivity to BTK degraders or any of the ingredients.
* Impaired cardiac function or clinically significant cardiac disease
* Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
* Major surgery within 4 weeks of the first dose of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06590961
Study Brief:
Protocol Section:
NCT06590961