Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06381141 | A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 30 | — | — | Sep 3, 2024 | Mar 1, 2027 | Sep 18, 2025 | 8 | United States |
Incidence of AEs and SAEs using MedDRA
ECOG Scores are a functional scale ranging from 0 (Fully active, able to carry out all pre-disease activities without restrictions) to 5 (Death)
Maximum Tolerated Dose (MTD) is reached if 2 or more patients experience a DLT at a dose level
The best response defined by the International Myeloma Working Group (IMWG) criteria recorded throughout the study including unscheduled assessments
The proportion of patients who achieve a partial response or better (e.g., Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) or stringent Complete Response (sCR), according to IMWG response criteria
The time from the earliest date of documented response to the first documented disease progression or death, whichever occurs first.
The proportion of patients with a best overall response of CR, PR and stable disease (SD), according to IMWG response criteria
The time from date of first dose until the earliest date of disease progression, or death from any cause, whichever occurs first.
Time from the date of first dose to date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation | EXPERIMENTAL | Cohorts of patients with R/R MM will be treated at ascending doses of CLN-619 using a standard 3+3 dose escalation design. |
| Name | Type | Description |
|---|---|---|
| CLN-619 | DRUG | Anti-MICA/MICB monoclonal antibody |
Inclusion Criteria: 1. Aged ≥ 18 years at the time of signing the ICF. 2. Willing and able to give written informed consent and adhere to protocol requirements. 3. Patient has a history of multiple myeloma with relapsed and refractory disease as defined by the protocol. 4. Patients must have measur...