Brief Introduction of CAR-T Cell Therapy Axicabtagene Ciloleucel(Yescarta)
Brief Introduction of CAR-T Cell Therapy Axicabtagene Ciloleucel(Yescarta)
1. Composition
Axicabtagene Ciloleucel (Yescarta) is a personalized immunocellular therapy that modifies a patient’s own T cells to fight cancer cells. It consists of two main components: the chimeric antigen receptor (CAR) and the CAR-modified T cells. These CAR-T cells are genetically engineered to possess an enhanced ability to identify and attack cancer cells.
Axicabtagene Ciloleucel(Yescarta)
2. Indications
Approved Indications in the United States
In October 2017, Axicabtagene Ciloleucel became the first FDA-approved CAR-T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.
The specific indications are: for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. (Limitation of use: Axicabtagene Ciloleucel is not indicated for the treatment of primary central nervous system lymphoma.)
In March 2021, Axicabtagene Ciloleucel received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The prescribing information states that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Approved Indications in the European Union
In August 2018, Axicabtagene Ciloleucel (Yescarta) was approved for marketing in the European Union.
The approved indications include: for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Approved Indications in China
In June 2021, Axicabtagene Ciloleucel was approved in China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
3. Treatment Process
The treatment process for patients receiving Axicabtagene Ciloleucel typically involves the following steps:
a. T cells are collected from the patient’s peripheral blood and sent to a laboratory for genetic modification.
b. In the laboratory, the T cells are genetically engineered to add the gene sequence encoding the CAR, enabling them to recognize and attack cancer cells.
c. The modified CAR-T cells are expanded and cultured, and then cryopreserved when enough cells are available.
d. The patient receives chemotherapy to prepare their body for the CAR-T cell treatment dose.
e. The cryopreserved CAR-T cells are thawed and infused intravenously into the patient to begin attacking the cancer cells.
f. The patient is closely monitored for potential side effects, which need to be addressed promptly.
4. Efficacy and Safety
Axicabtagene Ciloleucel has demonstrated significant efficacy in clinical trials. It can lead to tumor reduction or elimination in most patients, providing a new hope for those with severe conditions, ineligible for conventional therapies, or experiencing relapse. Due to its mechanism of action and the nature of potential side effects, severe adverse events such as cytokine release syndrome and neurotoxicity may occur during treatment. Therefore, patients need to be closely monitored and maintain communication with their healthcare providers to promptly address any complications.
Overall, Axicabtagene Ciloleucel (Yescarta), as a personalized immunocellular therapy, has the potential to treat complex lymphomas. Patients should undergo a comprehensive evaluation before receiving treatment and discuss appropriate treatment options and potential risks and benefits with their healthcare providers. While this innovative therapy offers hope for some patients, further research and monitoring are necessary during its application.