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AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS

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.

Table of contents

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.[1][2] The studies are looking at whether the treatment is safe, tolerable, and active against tumors.[1][2]

One study includes people with solid tumors, which are cancers that form a tumor mass.[1] The other study focuses on previously treated, unresectable or metastatic cutaneous melanoma, a type of skin cancer.[2]

Who can participate

The first trial is for patients with solid tumors.[1] 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.[2]

These are study-specific groups, so participation depends on the cancer type and the exact trial rules.[1][2]

Trial phases and design

The solid tumor study is a Phase 1/2 interventional trial.[1] Phase 1 checks early safety and helps find the right dose, while Phase 2 looks more closely at whether the treatment works against cancer.[1]

The melanoma study is a Phase 3 interventional trial.[2] 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.[2]

The Phase 1/2 study includes IMA203 and IMA203CD8, and it also studies IMA203 with nivolumab in some parts of the trial.[1] 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.[2]

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.[1] A dose-limiting toxicity is a side effect that may stop the dose from being increased or continued.[1]

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.[1] RECIST 1.1 is a standard method for measuring tumor change on scans.[1]

The Phase 3 melanoma trial measures progression-free survival, using a blinded independent central review and RECIST 1.1.[2] This means experts who do not know which treatment was given review the scans to see how long the cancer stays from getting worse.[2]

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.[1][2]

The solid tumor study has an enrollment of 543 patients, and the melanoma study has an enrollment of 384 patients.[1][2] These numbers show that the studies include a relatively large group for testing safety and effectiveness.[1][2]

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.[1] The melanoma trial aims to evaluate the efficacy of IMA203 compared with control treatment.[2]

Why these trials matter

These studies are important because they test the treatment in different cancer settings, from broad solid tumors to advanced melanoma.[1][2] 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.[1][2]

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.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT03686124 Phase 1/2 Solid tumors Authorised 543
NCT06743126 Phase 3 Previously treated, unresectable or metastatic cutaneous melanoma Authorised 384

FAQ

  • What is being studied in these clinical trials? The 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 main goals are to check safety, tolerability, and whether the treatment can help control the tumor.
  • Which cancer types are included? One trial includes people with solid tumors. Another trial focuses on previously treated, unresectable or metastatic cutaneous melanoma, which is a type of skin cancer.
  • What phases are these trials in? One study is in Phase 1/2, which means it is testing both early safety and later signs of benefit. The other study is in Phase 3, which compares the treatment against other treatment choices in a larger group.
  • Who may be able to join these trials? The trials are for people with solid tumors or cutaneous melanoma, depending on the study. The melanoma trial is for patients who have already been treated and still have unresectable or metastatic disease.
  • What are the main results the trials measure? The studies measure treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, objective response rate, and progression-free survival. These results help show if the treatment is safe and whether it delays cancer growth.

Ongoing Clinical Trials on AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS

  • Study on IMA203 for Patients with Previously Treated Unresectable or Metastatic Skin Melanoma

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany The Netherlands

  • Study on Treating Solid Tumors with Genetically Modified T-Cells (IMA203, IMA203CD8) and Nivolumab for Patients with Recurrent or Refractory Conditions

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany

Glossary

  • Solid tumors: Cancers that form a mass or lump, rather than affecting the blood or bone marrow.
  • Cutaneous melanoma: A serious type of skin cancer that starts in pigment-producing cells.
  • Phase 1/2: An early and mid-stage clinical trial phase that looks at safety first and then early signs of benefit.
  • Phase 3: A later trial phase that compares a new treatment with standard or other treatment choices in more people.
  • Safety: How well a treatment can be given without causing unacceptable harm.
  • Tolerability: How well patients can handle a treatment and its side effects.
  • Objective response rate: The percentage of patients whose tumors shrink or disappear based on scan results.
  • Progression-free survival: The length of time during and after treatment that the cancer does not get worse.
  • RECIST 1.1: A standard way to measure changes in tumor size on scans.
  • Blinded Independent Central Review: A review of scan results by experts who do not know which treatment a patient received.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of a treatment can be given.
  • Adverse events: Medical problems that happen during a study, whether or not they are caused by the treatment.

References