This study is a prospective, single-center, phase Ib/II clinical trial designed to evaluate the tolerability of sonrotoclax plus dexamethasone in this phase Ib/II umbrella study and to determine the recommended phase II dose (RP2D). It also aims to assess the safety and hematologic response rate of sonrotoclax plus dexamethasone in patients with newly diagnosed systemic light-chain amyloidosis (NDAL) harboring t(11;14), and of a BCMA/CD3 bispecific antibody in patients with NDAL without t(11;14). In addition, this study seeks to explore a chemotherapy-free treatment strategy based on t(11;14)-guided genetic stratification.
Able to understand and voluntarily sign the informed consent form (ICF).
Age ≥18 years and ≤70 years.
Confirmed diagnosis of primary light-chain amyloidosis, according to the diagnostic and treatment guidelines for primary light-chain amyloidosis, 2021 revised edition.
Subjects entering the phase Ib dose-escalation stage must also have confirmed t(11;14) translocation by FISH or other genetic testing.
Non-AL amyloidosis, including hereditary amyloidosis and other non-AL types of amyloidosis.
Diagnosis of symptomatic multiple myeloma, according to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma, 2022 revised edition. Patients whose diagnosis is based solely on a serum free light-chain ratio ≥100 are not excluded.
Peripheral neuropathy > grade 2 or painful neuropathy ≥ grade 2 at screening, regardless of whether the patient is currently receiving medication.
History of another malignancy, other than AL amyloidosis, within 5 years before randomization.
Parallel
Sonrotoclax
DrugAdministered orally daily
CM336 (BCMA/CD3 bispecific antibody)
DrugCM336 is a bispecific T-cell engager targeting B-cell maturation antigen (BCMA) and CD3. In this study, CM336 is administered subcutaneously with a step-up dosing strategy in Cycle 1 (3 mg Day 1, 20 mg Day 4, 40 mg Day 8 and onwards weekly).
Phase 1b: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
DLTs will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and will include most grade 3 or higher events, as defined in the protocol.
Phase 1b and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation, and Adverse Events of Special Interest (AESIs).
Phase 2: Rate of Hematologic Very Good Partial Response (VGPR) or Better
Proportion of participants achieving a hematologic response of VGPR or better (≥VGPR) of anti-BCMA/CD3 bispecific antibody (CM336), assessed using consensus criteria for AL amyloidosis hematologic response.
Time to First Hematologic Response (TTR)
Best Hematologic Response Achieved
The deepest hematologic response (e.g., PR, VGPR, CR, or sCR) observed at any time during the treatment period.
Duration of Hematologic Response (DOR)
Time from the first documented hematologic response to disease progression or death, whichever occurs first.
Overall Response Rate (ORR)
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