In short
Clinical trials are investigating AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS in people with solid tumors and cutaneous melanoma. These studies are looking at safety, tolerability, and how well the treatment works, including tumor response and progression-free survival.
Key points
- Clinical trials of AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS are being done in people with solid tumors and cutaneous melanoma. One study is Phase 1/2 and focuses on safety, tolerability, and early anti-tumor activity. The other is Phase 3 and compares the treatment with investigator’s choice in previously treated, unresectable or metastatic melanoma. Main outcomes include adverse events, dose-limiting toxicities, objective response rate, and progression-free survival. Both trials are authorised and are testing whether this approach can help control cancer in selected patient groups.
Trial overview
These clinical trials are studying AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS in cancer patients. The studies are looking at whether the treatment is safe, tolerable, and active against tumors.
One study includes people with solid tumors, which are cancers that form a tumor mass. The other study focuses on previously treated, unresectable or metastatic cutaneous melanoma, a type of skin cancer.
Who can participate
The first trial is for patients with solid tumors. The second trial is for patients with cutaneous melanoma that has already been treated and cannot be removed by surgery or has spread to other parts of the body.
These are study-specific groups, so participation depends on the cancer type and the exact trial rules.
Trial phases and design
The solid tumor study is a Phase 1/2 interventional trial. Phase 1 checks early safety and helps find the right dose, while Phase 2 looks more closely at whether the treatment works against cancer.
The melanoma study is a Phase 3 interventional trial. It compares AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS with investigator’s choice of treatment.
The Phase 1/2 study includes IMA203 and IMA203CD8, and it also studies IMA203 with nivolumab in some parts of the trial. The Phase 3 study compares IMA203 against several treatment options chosen by the investigator, such as nivolumab, paclitaxel, temozolomide, pembrolizumab, ipilimumab, dacarbazine, carboplatin, paclitaxel albumin-bound, and Opdualag.
What the trials measure
The first trial measures treatment-emergent adverse events, adverse events of special interest, serious treatment-emergent adverse events, and dose-limiting toxicities in Phase 1. A dose-limiting toxicity is a side effect that may stop the dose from being increased or continued.
In Phase 2 of the first study, the main cancer outcome is objective response rate, which means the number of patients whose tumors shrink or disappear based on scan review using RECIST 1.1. RECIST 1.1 is a standard method for measuring tumor change on scans.
The Phase 3 melanoma trial measures progression-free survival, using a blinded independent central review and RECIST 1.1. This means experts who do not know which treatment was given review the scans to see how long the cancer stays from getting worse.
Important study details
Both studies are listed as Authorised and are interventional trials, which means the researchers assign a treatment and then measure the results.
The solid tumor study has an enrollment of 543 patients, and the melanoma study has an enrollment of 384 patients. These numbers show that the studies include a relatively large group for testing safety and effectiveness.
The brief study goals for the solid tumor trial are to evaluate safety, tolerability, maximum tolerated dose or recommended Phase 2 dose, and anti-tumor activity. The melanoma trial aims to evaluate the efficacy of IMA203 compared with control treatment.
Why these trials matter
These studies are important because they test the treatment in different cancer settings, from broad solid tumors to advanced melanoma. They also use different trial phases, which helps researchers learn first about safety and later about how well the treatment may work compared with other options.
For patients, the key question in these trials is whether AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS can help control cancer while remaining safe enough to study further.