Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLN-619 · 2 trials · 3 indications
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.
Number of treatment-emergent events (TEAEs) TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
The percentage of patients having a CR or PR as determined by PI assessment of disease response per RECIST 1.1 on at least one scan.
The percentage of patients having a CR or PR as determined by PI assessment of disease response per RECIST 1.1.
The time from the earliest date of CR or PR until the earliest date of disease progression, as determined by PI assessment of disease response per RECIST 1.1 or death from any cause if occurring sooner than progression.
The percentage of participants having CR, PR, or SD as best on study response.
Time from the initial date of treatment until death.
The percentage of participants who achieve CR, PR or SD for a duration of 6 months as determined by PI assessment of disease response per RECIST 1.1.
| 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. |
| Module A Dose Escalation | EXPERIMENTAL | Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619 |
| Module A Cohort Expansion | EXPERIMENTAL | Patients with select solid tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module A Escalation arm |
| Module B Combination Therapy Dose Escalation | EXPERIMENTAL | Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619 in combination with pembrolizumab |
| Module B Combination Therapy Cohort Expansion | EXPERIMENTAL | Patients with select tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab |
| Module C Escalation and Expansion | EXPERIMENTAL | Patients with select tumor types taking CLN-619 in combination with chemotherapy |
| Module D Loading Dose | EXPERIMENTAL | Patients with select tumor types taking a loading dose of CLN-619 |
| Module E Safety Run-in and Expansion | EXPERIMENTAL | Patients with select NSCLC tumor types taking CLN-619 in combination with Dato-DXd |
| Name | Type | Description |
|---|---|---|
| CLN-619 | DRUG | Anti-MICA/MICB monoclonal antibody |
| Pembrolizumab | DRUG | Keytruda |
| Paclitaxel | DRUG | Taxane |
| Carboplatin AUC 6 | DRUG | Platinum compound |
| pemetrexed | DRUG | antifolate |
| Datopotamab deruxtecan-dlnk (Dato-DXd) | DRUG | TROP-2 antibody-drug conjugate (ADC) |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CLN-619 is an investigational small molecule being developed by Cullinan Therapeutics, Inc. for the treatment of advanced solid tumors and multiple myeloma. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is being studied both as a single agent and in combination with pembrolizumab.
CLN-619 is being studied for the treatment of advanced solid tumors, including non-small cell lung cancer, and for relapsed and refractory multiple myeloma. It is an investigational therapy in Phase 1 development and is not approved for any indication. Clinical testing is ongoing in adult patients with these cancer types.
CLN-619 targets MICA/B, which are stress-induced proteins expressed on the surface of tumor cells. By binding to MICA/B, CLN-619 is designed to support immune-mediated recognition and destruction of cancer cells. MICA/B belong to the protein target class.
CLN-619 is being developed by Cullinan Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol CGEM. The company is the sponsor of the clinical program evaluating CLN-619 in advanced solid tumors and multiple myeloma.
CLN-619 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes early-stage trials evaluating the drug in advanced solid tumors and in relapsed and refractory multiple myeloma.
CLN-619 is being evaluated in two Phase 1 trials. NCT05117476 studies CLN-619 alone and in combination with pembrolizumab in advanced solid tumors and NSCLC across the United States, Australia, Poland, and Spain. NCT06381141 studies CLN-619 in relapsed and refractory multiple myeloma in the United States.