Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLN-049 · 2 trials · 4 indications
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
CR (complete response) + CRh (complete remission with partial hematologic recovery) rate
Safety assessments include: body measurements, vital signs, physical exam, EGOG (measure of patient function in terms of self-care, daily activity, and physical ability) performance status, lab assessments, ECGs, and ECHO/MUGA (tests to evaluate heart function)
| 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 |
| Part D - Phase 2 Dose Optimization and Expansion | EXPERIMENTAL | Dose Optimization: patients will be randomized 1:1 to one of two dose regimens of CLN-049 via IV derived from doses tested during Part B (MAD-IV). Dose Expansion: patients will receive a single dose regimen of CLN-049 via IV as determined by Dose Optimization (RP2D). |
| Part E - Expansion of IV-administered CLN-049 in newly diagnosed AML patients with TP53 mutations | EXPERIMENTAL | Newly diagnosed, previously untreated AML patients with TP53 mutations will receive a single dose regimen of CLN-049 via IV as determined by Dose Optimization (RP2D). |
| Part A: Dose Escalation | EXPERIMENTAL | Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 in dose escalation cohorts |
| Part B: Dose Expansion | EXPERIMENTAL | Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 at a dose determined in Part A (Dose Escalation) |
| Name | Type | Description |
|---|---|---|
| CLN-049 | DRUG | \[FLT3\] x \[CD3\] bispecific T cell engager |
| Azacitidine | DRUG | Azacitidine 75 mg/m2 will initially be administered sub-cutaneous or intravenous on days 1 through 7 of a 28-day cycle |
| Venetoclax | DRUG | Venetoclax will initially be administered orally on days 1 through 28 of a 28-day cycle and then reduced to days 1 through 14 in consolidation cycles. |
Inclusion Criteria: 1. Aged ≥ 18 years of age. 2. Patient has a confirmed diagnosis of recurrent or refractory AML or MDS: Parts A, B, C: i. AML either de novo or secondary ii. MDS with at least 5% blasts that is relapsed after or refractory to hypomethylating agent (HMA) therapy iii. Patie...
CLN-049 is being developed for acute myeloid leukemia (AML), including relapsed or refractory AML, and for myelodysplastic syndrome (MDS), including TP53-mutated MDS and AML. It is an investigational small molecule in Phase 1 clinical development and has not been approved for any use.
CLN-049 targets FLT3, a protein kinase. By acting on FLT3, CLN-049 is designed to address AML and MDS, including relapsed or refractory disease and TP53-mutated cases. It is a small molecule and is being studied both as a single agent and in combination regimens.
CLN-049 is being developed by Cullinan Therapeutics, Inc., which trades under the ticker CGEM. The company is running the Phase 1 program in the United States, including a study of CLN-049 in relapsed or refractory AML and MDS and a Phase 1b combination study in AML.
CLN-049 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The FDA has granted CLN-049 Fast Track and Orphan Drug designations. The program includes a recruiting Phase 1 study and a Phase 1b combination study that is not yet recruiting.
CLN-049 is studied in NCT05143996, a recruiting Phase 1 trial in relapsed or refractory AML and MDS, including TP53-mutated disease, with planned enrollment of 275. It is also in NCT07722767, a Phase 1b study of CLN-049 combined with azacitidine and venetoclax in AML, planned for 90 patients and not yet recruiting.
CLN-049 is being tested both as a single agent and in combination. The Phase 1b trial NCT07722767 evaluates CLN-049 in combination with azacitidine and venetoclax in patients with AML. The Phase 1 trial NCT05143996 studies CLN-049 in relapsed or refractory AML and MDS, including TP53-mutated MDS and AML.