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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05143996 | CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) | PHASE1 | RECRUITING | 60 | — | — | Nov 18, 2021 | Jun 1, 2027 | Jan 16, 2026 | 11 | United States |
TEAEs will be defined as adverse events that are reported for the first time following study drug administration for worsening of a pre-existing event after the first dose
Maximum drug concentration
The observed plasma concentration just prior to the beginning of, or at the end of a dosing interval
Time to Cmax
28 Days
| Arm | Type | Description |
|---|---|---|
| Part A - Single ascending dose (SAD) design of IV administered CLN-049 | EXPERIMENTAL | Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration |
| Part B - Multiple ascending dose (MAD) design of IV administered CLN-049 | EXPERIMENTAL | Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration |
| Part C - Multiple ascending dose (MAD) design of SC administered CLN-049 | EXPERIMENTAL | Patients with relapsed/refractory AML or MDS will receive CLN-049 via SC injection |
| Name | Type | Description |
|---|---|---|
| CLN-049 | DRUG | \[FLT3\] x \[CD3\] bispecific T cell engager |
Inclusion Criteria: 1. Aged ≥ 18 years of age. 2. Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required authorization must be obtained from the patient prior to performing any protocol-related procedures, including s...