Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLN-049 · 2 trials · 3 indications
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)
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: 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) |
| 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 | CLN-049 will be initiated using two step-up doses (SUDs), followed by the first target dose (TD) one week later, and weekly thereafter. |
| 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. Patients aged ≥ 18 years of age with newly diagnosed, previously untreated AML (including MDS/AML) 2. Patients are not candidates for intensive induction chemotherapy because they are either unfit or otherwise clinically unsuitable for anthracycline/ cytarabine-based inductio...
CLN-049 is an investigational small molecule being studied for the treatment of relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It is also being evaluated in combination with azacitidine and venetoclax for AML patients. The drug is currently in Phase 1 clinical development.
CLN-049 is being developed by Cullinan Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CGEM. The company is conducting clinical trials of CLN-049 in the United States for the treatment of acute myeloid leukemia and related conditions.
CLN-049 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug has received Fast Track and Orphan Drug designations from the FDA for its intended indications.
CLN-049 is being studied in two Phase 1 clinical trials. The first trial, NCT05143996, is recruiting patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. The second trial, NCT07722767, is a Phase 1b study of CLN-049 in combination with azacitidine and venetoclax in AML patients, which has not yet started recruiting.
No, CLN-049 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted CLN-049 Fast Track and Orphan Drug designations, which are intended to expedite the development and review of drugs for serious conditions, but the drug remains in clinical development.