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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 studying 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 mainly look at safety, tolerability, and signs of anti-tumor activity, and one phase 3 trial compares it with other treatments in previously treated melanoma.

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] The data provided show two authorised interventional trials, one in solid tumors and one in cutaneous malignant melanoma.[1][2]

The first study, NCT03686124, is a Phase 1/2 trial in solid tumors.[1] It evaluates the treatment as monotherapy and also in combination with nivolumab, which is named in the trial record.[1]

The second study, NCT06743126, is a Phase 3 trial in previously treated, unresectable or metastatic cutaneous melanoma.[2] It compares ACTengine® IMA203 with the investigator’s choice of treatment.[2]

Who can participate

Based on the trial records, the target groups are patients with solid tumors in one study and people with previously treated, unresectable or metastatic cutaneous melanoma in the other.[1][2] “Unresectable” means the cancer cannot be removed with surgery, and “metastatic” means it has spread to other parts of the body.

The provided data do not list all detailed entry rules, such as age limits or laboratory requirements.[1][2] For that reason, the clearest way to describe participation is by the cancer types named in each study.[1][2]

Trial phases and design

NCT03686124 is a Phase 1/2 trial.[1] Phase 1 usually looks first at safety and dose, while Phase 2 looks more closely at early signs that the treatment may work.[1]

NCT06743126 is a Phase 3 trial.[2] Phase 3 studies are larger and compare one treatment with other available options to see how well it performs in a real treatment setting.[2]

Both studies are interventional, which means the research team gives a treatment and then measures the results.[1][2]

What the trials measure

The Phase 1/2 trial measures treatment-emergent adverse events, adverse events of special interest, serious treatment-emergent adverse events, and dose-limiting toxicities.[1] These are ways to track safety and whether side effects are serious enough to limit treatment.[1]

The same study also measures objective response rate in Phase 2, using RECIST 1.1 rules and central review.[1] This tells researchers how many patients have a complete response or partial response, meaning the cancer disappears or shrinks.[1]

The Phase 3 melanoma trial measures progression-free survival, checked by a Blinded Independent Central Review using RECIST 1.1.[2] This endpoint shows how long patients live without the cancer getting worse.[2]

Main study details

NCT03686124 includes 543 participants and is authorised.[1] Its brief summary says the study aims to evaluate safety and tolerability of ACTengine® IMA203/IMA203CD8 as monotherapy or with nivolumab, determine the maximum tolerated dose and/or recommended Phase 2 dose, and assess anti-tumor activity of IMA203.[1]

NCT06743126 includes 384 participants and is also authorised.[2] Its brief summary says the goal is to evaluate the efficacy of IMA203 compared with control treatment chosen by the investigator.[2]

The trial records also list the treatment options used in the comparison arm of the melanoma study, including nivolumab, paclitaxel, temozolomide, paclitaxel albumin-bound, carboplatin, pembrolizumab, ipilimumab, dacarbazine, and Opdualag.[2] These are listed as the control choices in the study record, not as the main focus of this article.[2]

Key patient terms

  • Safety: whether the treatment causes problems or unwanted effects during the study.[1]

  • Tolerability: how well patients can receive the treatment without major difficulty.[1]

  • Monotherapy: treatment used alone, not with another study drug.[1]

  • Combination therapy: treatment given together with another drug, such as nivolumab in the Phase 1/2 study.[1]

  • Maximum tolerated dose: the highest dose that can be given without causing too many serious side effects.[1]

  • Recommended Phase 2 dose: the dose chosen for later testing based on early safety results.[1]

  • Anti-tumor activity: signs that the treatment may help fight the cancer.[1]

  • Investigator’s choice: the doctor or study team chooses from allowed treatment options in the trial.[2]

Trial IDPhaseCondition studiedStatusEnrollment
NCT03686124Phase 1/2Solid tumorsAuthorised543
NCT06743126Phase 3Cutaneous malignant melanomaAuthorised384

FAQ

  • What are the clinical trials studying? The trials are testing AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS in cancer, mainly solid tumors and cutaneous melanoma. They focus on whether the treatment is safe and whether it helps control the cancer.
  • Who may take part in these trials? One trial includes patients with solid tumors, and another includes people with previously treated, unresectable or metastatic cutaneous melanoma. Exact entry rules are not listed in the data provided.
  • What trial phases are included? The studies include a Phase 1/2 trial and a Phase 3 trial. The earlier-phase study looks at safety, dose, and early activity, while the Phase 3 study compares the treatment with other options.
  • What outcomes are being measured? The trials measure treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, and objective response rate. The Phase 3 trial measures progression-free survival, which means how long patients live without the cancer getting worse.
  • How many trials are listed here? Two interventional trials are listed. Both are authorised and study the treatment in different cancer settings.

Sperimentazioni cliniche in corso su AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS

  • Studio sull’efficacia di IMA203 rispetto a una combinazione di farmaci in pazienti con melanoma cutaneo non operabile o metastatico già trattato

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Francia Germania Paesi Bassi

  • Studio su IMA203, IMA203CD8 e nivolumab per pazienti con tumori solidi ricorrenti o refrattari

    In arruolamento

    1 1 1
    Farmaci in studio:
    Germania

Glossario

  • Solid tumors: Cancers that form a mass or lump in an organ or tissue, such as in the lung, colon, or skin.
  • Cutaneous melanoma: A serious type of skin cancer that starts in pigment-producing cells.
  • Interventional study: A trial where researchers give a treatment and then watch what happens.
  • Phase 1/2: An early trial stage that first checks safety and dose, then looks for early signs that the treatment may work.
  • Phase 3: A later trial stage that compares a treatment with standard or chosen control treatments in a larger group of patients.
  • Safety and tolerability: How well patients can receive a treatment and what side effects or problems happen.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much treatment can be given.
  • Objective response rate: The percentage of patients whose tumors shrink or disappear based on scan rules.
  • Progression-free survival: The length of time during and after treatment when the cancer does not get worse.
  • RECIST 1.1: A standard set of rules used to measure whether tumors shrink, stay the same, or grow.
  • Blinded Independent Central Review: A review of scan results by experts who do not know which treatment the patient received.

Riferimenti

  1. https://studi-clinici.it/studio/studio-su-ima203-ima203cd8-e-nivolumab-per-pazienti-con-tumori-solidi-ricorrenti-o-refrattari/
  2. https://studi-clinici.it/studio/studio-sullefficacia-di-ima203-rispetto-a-una-combinazione-di-farmaci-in-pazienti-con-melanoma-cutaneo-non-operabile-o-metastatico-gia-trattato/