CAR-T-Cell Therapy: A Breakthrough in Cancer Care
- Published | 22 August 2024
Chimeric antigen receptor (CAR) T-cell therapy is a technique that uses genetic engineering to modify T cells, a subset of white blood cells, to enable them to recognize and eliminate cancerous cells. Because CAR T-cell therapy modifies T cells' genes to enable them to fight cancer, it is occasionally referred to as a form of cell-based gene therapy.
Even in cases where alternative treatments are no longer effective, this kind of care can help treat specific cancers.
How CAR T-cell therapy work
In CAR T-cell therapies, T cells are taken from the patient's blood and are changed in the lab by adding a gene for a receptor (called a chimeric antigen receptor or CAR), which helps the T cells attach to a specific cancer cell antigen. The CAR T cells are then given back to the patient.
CAR T-cell therapy can take a few weeks to complete.
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Leukapheresis is the first procedure used to separate white blood cells (including T cells) from the patient's blood. Patients typically lie in bed or recline in a reclining chair for this operation. Because blood is drawn from one IV line, white blood cells are extracted, and then the blood is reinfused, two IV lines are required. Patients typically lie in bed or recline in a reclining chair for this operation. White blood cells are extracted from the blood through one IV line, and the blood is reinfused into the body through the other, necessitating the use of two IV lines. Central venous catheters, a unique kind of IV line with both IV lines integrated in, are occasionally utilized.
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For two to three hours during the process, the patient will need to remain seated or in a prone position. During leukapheresis, blood calcium levels might occasionally fall, which can result in tingling and numbness as well as muscle spasms. The replacement of calcium, which can be either intravenously or orally, can be used to treat this.
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Once the white cells are extracted, the T cells are isolated, transferred to a laboratory, and manipulated by introducing the gene corresponding to the particular chimeric antigen receptor (CAR). They are therefore CAR T cells. Then, in the lab, these cells are expanded and multiplied. The production of the vast quantity of CAR T cells required for this treatment can take many weeks.
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Once sufficient CAR-T cells have been produced, they will be returned to the patient. The patient may get chemotherapy a few days before to the CAR T-cell infusion in order to assist reduce the quantity of other immune cells. This increases the likelihood that the CAR T cells will become activated to combat the malignancy. Because CAR T cells function best while there are still some cancer cells to assault, this chemotherapy is typically not very strong. The CAR T cells proliferate and have the ability to aid in the destruction of other cancer cells once they attach to cancer cells.
Some of the approved CAR T-cell therapies include:
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Tisagenlecleucel, also known as tisa-cel (Kymriah)
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Axicabtagene ciloleucel, also known as axi-cel (Yescarta)
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Brexucabtagene autoleucel, also known as brexu-cel (Tecartus)
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Lisocabtagene maraleucel, also known as liso-cel (Breyanzi)
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Idecabtagene vicleucel, also known as ide-cel (Abecma)
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Ciltacabtegene autoleucel, also known as cilta-cel (Carvykti)
Market Of CAR-T Cell Therapy
The market for CAR T-cell treatment was estimated to be worth USD 2.75 billion globally in 2022. From 2023 to 2030, it is projected to expand at a compound annual growth rate (CAGR) of 23.32%, peaking at USD 15.97 billion. Increased cancer prevalence, clinical success, regulatory approvals, and expanding indications are some of the factors driving the market. But the medications' side effects and exorbitant costs could also impede expansion.
The pipeline highlights of CAR-T cell therapy are following
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In August 2023, the US FDA granted orphan drug designation (ODD) to NXC-201 (Nexcella), a next generation chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients suffering from multiple myeloma.
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In August 2023, Invectys announced that FDA granted a Fast Track Designation to the chimeric antigen receptor (CAR) T-cell therapy, IVS-3001, which is used for the treatment of patients suffering from renal cell carcinoma.
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In August 2023, GenScript Biotech entered into a strategic agreement with T-MAXIMUM Biotech with an aim to develop CAR T cell therapy by using GenScript’s CRISPR nucleic acid reagents
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In January 2023, CARsgen Therapeutics had announced a collaboration with Huadong Medicine to commercialize zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. Under the collaboration, Huadong Medicine will have the exclusive right to commercialize CARsgen’s CT053 in mainland China. According to the deal, CARsgen will receive $29.7m (RMB200m) in upfront payment and is also eligible for up to $152.4m (RMB1,025m) in regulatory and commercial milestones.
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In December 2022, Arcellx, Inc. announced a global strategic collaboration to co-develop and co-commercialize Arcellx's lead late-stage product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma. Currently in Phase 2 clinical development, CART-ddBCMA is an investigational cell therapy product comprising autologous T cells that have been genetically modified to target multiple myeloma. CART-ddBCMA utilizes Arcellx's novel D-Domain binder. Kite and Arcellx will jointly advance the CART-ddBMCA asset.
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In December 2022, CARsgen Therapeutics Holdings Limited announced that at the 2022 American Society of Hematology (the "ASH") Annual Meeting, the Company presented a poster with the results of the phase I/II LUMMICAR STUDY 1 clinical trial of zevorcabtagene autoleucel. Results for the 14 subjects treated in phase I of LUMMICAR STUDY 1 showed a well-tolerated safety profile, plus deep and durable responses with an objective response rate (ORR) of 100% and a complete response/stringent complete response (CR/sCR) rate of 78.6%.
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In October 2022, CARsgen Therapeutics Holdings Limited announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel for the treatment of relapsed and/or refractory multiple myeloma (R/R MM). The acceptance of the NDA was based on data from an open-label, single arm Phase I/II clinical trial (LUMMICAR STUDY 1 [Protocol number CT053-MM-01]) in China. Study results showed that zevor-cel has excellent safety and efficacy profiles. Zevor-cel also represents a promising treatment option for patients with high-risk disease.
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In August 2022, Poseida Therapeutics, Inc. announced it has entered into a broad strategic collaboration and license agreement with Roche, focused on developing allogeneic CAR-T therapies directed to hematologic malignancies. The global collaboration covers the research and development of multiple existing and novel "off-the-shelf" cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications.
Conclusion
CAR T-cell therapy is a rapidly growing segment within the broader immunotherapy market, offering a transformative approach to cancer treatment. The therapy involves modifying a patient's T cells to recognize and destroy cancer cells, providing personalized and highly targeted treatment. The CAR T-cell therapy market is expected to grow significantly due to advancements in biotechnology and increasing approval of CAR T-cell therapies for various cancer types. Ongoing research and development are likely to result in more effective therapies with fewer side effects. The market is becoming increasingly competitive, with several biotech and pharmaceutical companies developing CAR T-cell therapies. Collaborations, mergers, and acquisitions are common as companies seek to strengthen their portfolios and market positions.
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