Observational Study on the Association Between Second Cancers Following CAR-T Cell Therapy and Drugs Manufactured by Bristol-Myers Squibb (Idecabtagene vicleucel (Abecma); Lisocabtagene maraleucel (Breyanzi))
- Gender
- Women and men
- Age
- 0 years and older
- Trial type
- Observational
- Line of therapy
- First line
- Phase
- Phase IV
What is this trial about?
CAR-T cell therapy is a novel and effective form of treatment for various types of cancer. During the production of CAR-T cells, the selected cells are genetically modified. It is possible that, in connection with these genetically modified cells, the administration to patients could lead to the development of another malignant tumor (secondary tumor) as a potential long-term complication. This study is investigating CAR-T cell therapies from the pharmaceutical company Bristol-Myers Squibb to determine whether there is a link to secondary tumors. Eligible participants include women and men with a newly diagnosed secondary tumor who have previously received treatment with a genetically modified drug (CAR-T cell therapy) from the pharmaceutical company Bristol-Myers Squibb.
Detailed description
CAR-T cell therapy is a novel treatment approach for various forms of cancer that has been shown to be highly effective in numerous studies. CAR-T cells are now also being used outside of clinical trials, with various pharmaceutical companies manufacturing them. In this process, immune cells (T cells) are extracted from patients and genetically modified in a laboratory so that they can recognize and eliminate tumor cells once the modified cells are returned to the patient as a single infusion. This form of therapy is therefore classified as a genetically modified cell therapy. In the use of CAR-T cells to date, it has been observed in isolated cases that patients develop a second malignant tumor following CAR-T cell therapy. The exact cause of this secondary disease is not yet known. Initially, it was suspected that the new cancer might have developed from the genetically modified cells used in CAR-T cell therapy. However, more recent studies suggest that the new cancer cells were already present in the body prior to CAR-T cell therapy and were able to proliferate more easily due to the therapy-induced weakening of the immune system.
The goal of the study is to genetically analyze tissue from such a secondary tumor in patients who have received gene-modified cell therapy with a drug from the pharmaceutical company Bristol-Myers Squibb, and to examine a possible link to the previously administered CAR-T cell therapy. For this purpose, a tissue sample of the tumor is required from the patients. No new form of therapy is being tested as part of this study.
Women and men with a newly diagnosed secondary tumor following successful CAR-T cell therapy with a drug from Bristol-Myers Squibb are eligible to participate in this study. The drugs in question are: Breyanzi® (lisocabtagen maraleucel) or Abecma® (idecabtagen vicleucel).
Facts
- What condition: Secondary cancer following CAR-T cell therapy with Breyanzi® or Abecma®.
- Cancer characteristics: Prior treatment of another cancer with a CAR-T cell therapy from Bristol-Myers Squibb (Breyanzi® or Abecma®).
- What the study investigates: A specialized analysis of a tissue sample from the secondary tumor using a test developed by Bristol-Myers Squibb.
- Study objective: To determine whether the new tumor could be related to the CAR-T cell therapy (detection of CAR transgenes in the secondary tumor).
- Duration of the study: A single tissue examination upon the recurrence of the secondary cancer.
- Study characteristics: Observational study/registry; no new form of therapy.
Trial sites
1 trial site in Germany is listed.
Universitätsklinikum Essen
45147 Essen
Recruiting
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT06357754) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.