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Anitocabtagene Autoleucel

Clinical trials of Anitocabtagene Autoleucel are studying its use in multiple myeloma, a cancer of plasma cells in the bone marrow. The trials are looking at safety, response rates, and disease control in people with newly diagnosed or relapsed/refractory disease. They include Phase 2 and Phase 3 studies in adults who meet specific prior-treatment criteria.

Table of Contents

Trials overview

Two interventional studies are investigating Anitocabtagene Autoleucel in multiple myeloma, which is a cancer of plasma cells in the bone marrow.[1][2] One study is in people with newly diagnosed disease, and the other is in people with relapsed/refractory disease, meaning the cancer came back or did not respond well to earlier treatment.[1][2] The studies are listed as authorised.[1][2]

Phase 2 study in newly diagnosed multiple myeloma

The first trial is a Phase 2, open-label study in participants with newly diagnosed multiple myeloma according to IMWG criteria.[1] Open-label means everyone in the study knows which treatment is being given.[1] This study aims to evaluate the safety and efficacy of Anitocabtagene Autoleucel after induction therapy, which means treatment given before the main study therapy.[1]

The brief summary says the study is designed to characterize safety after induction therapy and to further characterize the efficacy profile in this newly diagnosed group.[1] The planned enrollment is 30 participants.[1]

Phase 3 study in relapsed/refractory multiple myeloma

The second trial is a Phase 3 study comparing Anitocabtagene Autoleucel with standard of care therapy in participants with relapsed/refractory multiple myeloma.[2] This study is larger and is meant to compare how well the treatment works against usual treatment options.[2] It includes patients who have had 1 to 3 prior lines of therapy and have been exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody.[2]

The brief summary states that the study will compare the efficacy of Anitocabtagene Autoleucel versus standard of care therapy in relapsed/refractory multiple myeloma.[2] The planned enrollment is 642 participants.[2]

Who can participate

Eligibility is different for each trial.[1][2] In the Phase 2 study, participants must have newly diagnosed multiple myeloma according to IMWG criteria.[1] In the Phase 3 study, participants must have relapsed/refractory multiple myeloma, 1 to 3 prior treatment lines, and prior exposure to both an immunomodulatory drug and an anti-CD38 monoclonal antibody.[2]

  • Newly diagnosed group: people whose multiple myeloma has just been found and who meet IMWG diagnostic rules.[1]

  • Relapsed/refractory group: people whose disease returned after treatment or did not respond well enough, and who already received several prior therapies.[2]

What the trials measure

The Phase 2 study measures the incidence, seriousness, and severity of all adverse events, which are medical problems that happen during a study.[1] It also measures the rate of uMRD negative complete response at 12 months, with a small allowed time window of plus or minus 3 months after enrollment.[1] uMRD means undetectable minimal residual disease, so this endpoint checks whether no tiny signs of disease can be found by the study test level used in the trial.[1]

The Phase 3 study measures progression-free survival, which is the time until the disease gets worse or death occurs from any cause, whichever happens first.[2] It also measures MRD-negative complete response at 9 months, using bone marrow testing and IMWG response rules assessed by an independent review committee.[2] MRD negativity in this trial means a negative test result at 9 months, with a small allowed time window of plus or minus 3 months.[2]

  • Adverse events: unwanted medical problems that happen during the study.[1]

  • Complete response: a strong treatment result where disease is not found by the study rules.[1][2]

  • Bone marrow assessment: a test of the soft tissue inside bones where myeloma cells are found.[2]

  • Independent review committee (IRC): a separate group that checks study results in a fair way.[2]

Trial status and size

Both studies are listed as authorised, meaning they have been approved to proceed in the provided trial data.[1][2] The Phase 2 study plans to enroll 30 participants, while the Phase 3 study plans to enroll 642 participants.[1][2] The difference in size fits the different goals of the studies: early safety and response checking in a smaller group, and comparison with standard care in a larger group.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-517020-18-00 Phase 2 Newly diagnosed multiple myeloma according to IMWG criteria Authorised 30
NCT06413498 Phase 3 Relapsed/refractory multiple myeloma after 1 to 3 prior lines of therapy, with exposure to an immunomodulatory drug and an anti-CD38 monoclonal antibody Authorised 642

FAQ

  • What is being studied in the Anitocabtagene Autoleucel trials? The trials are testing Anitocabtagene Autoleucel in multiple myeloma. One study looks at people with newly diagnosed disease after induction therapy, and another compares it with standard of care in relapsed/refractory disease.
  • Who can join these trials? One trial includes participants with newly diagnosed multiple myeloma according to IMWG criteria. The other includes people with relapsed/refractory multiple myeloma who have had 1 to 3 prior lines of therapy and were exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody.
  • What phases are the studies in? There is one Phase 2 study and one Phase 3 study. Phase 2 usually looks more closely at safety and early effectiveness, while Phase 3 compares the treatment with standard care in a larger group.
  • What results are the trials measuring? The studies measure safety, including the number and severity of adverse events, and treatment effect. They also look at complete response, minimal residual disease negativity, and progression-free survival, which means the time before the disease gets worse or the person dies.
  • Are these trials still open? Both trials are listed as authorised. That means they have been approved to start, based on the information provided.

Ongoing Clinical Trials on Anitocabtagene Autoleucel

  • Study Comparing Anitocabtagene Autoleucel with Standard Treatment for Patients with Relapsed or Refractory Multiple Myeloma

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +3

  • Study on the Safety and Effectiveness of Anitocabtagene Autoleucel and Drug Combination for Patients with Newly Diagnosed Multiple Myeloma

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • Multiple myeloma: A cancer of plasma cells, which are a type of white blood cell found in the bone marrow.
  • Newly diagnosed: A disease that has been found for the first time.
  • Relapsed/refractory: Relapsed means the cancer came back after treatment. Refractory means it did not respond well to treatment.
  • IMWG criteria: Rules from the International Myeloma Working Group used to diagnose and judge response in multiple myeloma.
  • Phase 2: A study stage that looks at safety and early signs of benefit in a smaller group.
  • Phase 3: A larger study stage that compares a treatment with standard care to better see how well it works.
  • Open-label: A study where both the researchers and participants know which treatment is being given.
  • Standard of care: The usual treatment used in routine medical care.
  • Adverse events: Medical problems or unwanted effects that happen during a study.
  • Complete response: A very strong treatment result where signs of disease are no longer found by the study rules.
  • Minimal residual disease (MRD): Very small amounts of cancer left in the body after treatment, which may only be seen with special tests.
  • Progression-free survival (PFS): The length of time a person lives without the cancer getting worse.

References