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ARLOCABTAGENE AUTOLEUCEL

Clinical trials are investigating ARLOCABTAGENE AUTOLEUCEL in people with multiple myeloma and in long-term follow-up after earlier gene-modified T-cell treatment. These studies look at safety, long-term effects, and how well the treatment works in adults and some pediatric patients. One trial also compares it with standard treatments in relapsed or refractory disease.

Table of contents

Overview of the trials

Two clinical trials in the provided data are linked to ARLOCABTAGENE AUTOLEUCEL. One is a long-term follow-up study for people who already received a genetically modified T-cell infusion in an earlier Celgene-sponsored study, and the other is a Phase 3 study in relapsed or refractory multiple myeloma exposed to lenalidomide.[1][2]

Both studies are interventional, which means they involve planned treatment or follow-up steps rather than only observation.[1][2]

Long-term follow-up study

The study NCT03435796 is an authorised Phase 4 long-term follow-up protocol for subjects treated with gene-modified T cells.[1] It plans to enroll adult and paediatric subjects who received at least one genetically modified T-cell infusion in a previous Celgene-sponsored study.[1]

The main goal is to watch for delayed adverse events, meaning side effects that appear later after treatment, including neurologic, autoimmune, hematologic, infectious, and hospitalization-related events.[1] The study also checks whether the gene-modified T-cell products stay in the body over time and, for one cohort, whether there is any replication competent lentivirus, which is a safety check for a virus that could still copy itself.[1]

For children, the study also follows physical growth and sexual maturity, and it continues until Tanner stage 5 is reached.[1] The assessments begin 3 months after the last infusion, continue every 6 months until month 60, and then happen once a year until the end of the study, with a total safety and efficacy follow-up of up to 15 years from the last infusion.[1]

Phase 3 study in relapsed or refractory multiple myeloma

The study NCT06615479 is an authorised Phase 3 trial in participants with relapsed or refractory multiple myeloma who have been exposed to lenalidomide.[2] It is designed to see if arlo-cel works better than standard treatments, specifically daratumumab with pomalidomide and dexamethasone or carfilzomib with dexamethasone.[2]

This study includes a GPRC5D-directed CAR T cell therapy, listed in the source as GPRC5D-TARGETED CAR T, together with comparison treatment options and supportive medicines used in the study plan.[2] The brief summary says the study compares the treatment using two main effectiveness measures.[2]

Main outcomes being measured

In the long-term follow-up study, the main safety outcomes include delayed adverse events, persistence of the gene-modified T-cell product, analysis of vector integration sites in one cohort, and incidence of RCL in one cohort.[1] The study also looks at overall survival in participants whose original diagnosis was a malignancy, and at the proportion of subjects who progressed during the study.[1]

In the Phase 3 multiple myeloma study, the main outcomes are progression-free survival, which means the time before the disease gets worse, and minimal residual disease-negative complete response, which means no signs of myeloma can be found in the body.[2]

Who can take part

The long-term follow-up study includes all adult and paediatric subjects who had at least one genetically modified T-cell infusion in a previous Celgene-sponsored study.[1] This makes it a follow-up group rather than a new treatment group.[1]

The Phase 3 myeloma study includes participants with relapsed or refractory disease who have already been exposed to lenalidomide.[2] The trial is focused on people whose myeloma has come back or has not responded well to earlier treatment.[2]

Simple explanation of key terms

Interventional study means the researchers give a planned treatment or follow-up schedule and then measure the results.[1][2]

Authorised means the study has been approved to run.[1][2]

Enrollment is the number of people planned for the study, which is 1410 in the long-term follow-up trial and 440 in the Phase 3 myeloma trial.[1][2]

Overall survival means how long people live after entering the study.[1]

Vector integration sites are places in the body’s cells where the gene therapy material has inserted, and the study checks these for safety.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03435796 Phase 4 Long-term follow-up after gene-modified T-cell treatment Authorised 1410
NCT06615479 Phase 3 Relapsed or refractory multiple myeloma, lenalidomide exposed Authorised 440

FAQ

  • What is being studied in trials of ARLOCABTAGENE AUTOLEUCEL? The trials study ARLOCABTAGENE AUTOLEUCEL in multiple myeloma and in long-term follow-up after gene-modified T-cell treatment. They focus on safety, long-term persistence of the treatment, and how well it controls the disease.
  • Who can take part in these trials? One trial includes adults and children who previously received at least one infusion of genetically modified T cells in an earlier Celgene-sponsored study. Another trial includes people with relapsed or refractory multiple myeloma who have already been exposed to lenalidomide.
  • What phases are the trials? The long-term follow-up study is Phase 4. The multiple myeloma comparison study is Phase 3.
  • What results are the trials measuring? The studies measure delayed side effects, survival, disease progression, and in some patients the level of disease response. The long-term study also checks growth and sexual maturity in children.
  • What conditions are being studied? The main condition is relapsed or refractory multiple myeloma. One study also follows people treated earlier with gene-modified T cells, regardless of the original disease, if they were part of a previous sponsored study.

Sperimentazioni cliniche in corso su ARLOCABTAGENE AUTOLEUCEL

  • Studio sulla terapia con arlocabtagene autoleucel rispetto ai trattamenti standard per adulti con mieloma multiplo recidivante o refrattario

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Austria Belgio Cechia Danimarca Finlandia Francia +11

  • Studio di follow-up a lungo termine per pazienti trattati con idecabtagene vicleucel o lisocabtagene maraleucel

    In arruolamento

    1 1 1
    Farmaci in studio:
    Austria Belgio Cechia Danimarca Finlandia Francia +11

Glossario

  • Multiple myeloma: A cancer of plasma cells, which are a type of blood cell found in the bone marrow.
  • Relapsed: A disease that came back after a period of improvement.
  • Refractory: A disease that does not respond well to treatment.
  • Lenalidomide exposed: The person has already received lenalidomide before entering the study.
  • Phase 3: A late-stage clinical trial that compares a new treatment with standard care in a larger group of people.
  • Phase 4: A study done after a treatment has already been studied earlier, often to collect long-term safety information.
  • Progression-free survival: The length of time a person lives without the cancer getting worse.
  • Minimal residual disease: Very small amounts of cancer that may remain after treatment and are hard to detect.
  • Complete response: No signs of the disease can be found after treatment.
  • Delayed adverse events: Side effects that happen later, not right after treatment.
  • Replication competent lentiviruses: A safety check for viruses that could still copy themselves after being used in the treatment process.
  • Tanner stage 5: A stage of full physical sexual maturity used in children and teenagers.

Riferimenti

  1. https://studi-clinici.it/studio/studio-di-follow-up-a-lungo-termine-per-pazienti-trattati-con-idecabtagene-vicleucel-o-lisocabtagene-maraleucel/
  2. https://studi-clinici.it/studio/studio-sullefficacia-di-bms-986393-rispetto-a-terapie-standard-in-pazienti-adulti-con-mieloma-multiplo-recidivante-o-refrattario-e-refrattario-a-lenalidomide/