CAR T-Cell therapy in India
March, 2023: Some cancer centres in India have started CAR T-Cell therapy for DLBCL, BALL, Multiple Myeloma, Gliomas, liver, pancreatic, colon, lung, cervical and GI based cancers with the help of a Malaysian company, apart from current ongoing clinical trials in ACTREC and Narayana, Bengaluru. These centres are providing the infusion of CAR T Cells in collaboration with Malaysian Genomic Resource Centre. MGRC has collaborated with China based CAR Cell biotech company to bring this therapy in India. In this therapy patients white blood cells are extracted and then chimeric agent receptor (CAR) is transferred to the T-Cells. For this process patient’s cells are transported to the biotech facility in Malaysia. These CAR T Cell are then infused back in the patient. These processed cells binds with cancer cells and kills them.
Home grown CAR T-Cell therapy is developing at a very rapid pace in India. After approvals it is believed that CAR T-Cell therapy in India will cost as low as $ 20,000 USD. Hospitals in India namely Tata memorial & CMC, Vellore have already started trials. This will save the life of hundreds of patients battling with some type of blood cancer. At present this life saving therapy is available in USA, UK, Canada, Israel, Singapore, China, Malaysia & Australia. Very soon it will be available in India, South – Korea & Japan too. Cost of this therapy is around $ 5-7,00,000 USD in USA, whereas in China it cost anywhere between $ 70-80,000 USD.
Clinical trials for CAR T- Cell therapy for treatment of some types of blood cancer trials have kicked off at the Advanced Centre for Treatment, Research and Education in Cancer the research and development wing of Tata Memorial Centre. “More details of the trial will be revealed soon,” Dr. Narula said in a press brief. This clinical trial is taking place with the help of researcher from IIT, Bombay who has developed this life saving therapy. I twill take some time before it is commercially available.
Photo: TMH is one of the hospitals in India where CAR T Cell therapy trials have begun.
Dr Reddys lab has also secured a deal with Shenzen Biopharma Pregene of China in the month of May, 21 to bring this life saving therapy to India. It’s just a matter of time when CAR T-Cell therapy will also be available very soon in India.
There are several other companies that are also working to bring this technology to India. US-based Indian born oncologist Dr. Siddharth Mukherjee was in India recently and had a meeting with Kiran Mazumdar Shaw of Biocon & Mr. Kush Parmar of 5 AM ventures. All of them have agreed to come up with a facility to grow a Chimeric Antigen Receptor (CAR) cells to fight cancer. As per the reports, this therapy can be available in India in about a year’s time. This therapy has recently been approved by FDA (Food and drug administration). This cell therapy is useful for treatment in certain children and young adults suffering from Non – Hodgkin lymphoma. Treatment with Yeskarta & Kymriah is the first CAR T-Cell therapy to receive FDA approval.
Despite the fact that there are multiple cell therapy clinical trials active and enrolling in the United States, the European Union, and China, none have been available in India.
The new Immuneel facility in Bengaluru’s Narayana Health City is dedicated to introducing high-quality and affordable cell therapies to India. The facility’s strategic location in a tertiary care hospital near a high-volume bone marrow transplant unit allows for further coordination between research teams and clinicians, which is important for focused clinical development of innovative personalized therapies like CAR-T.
Immuneel is working hard to advance its pipeline. The company’s strategy of licensing a CAR-T asset that has already been clinically tested is expected to result in the company’s first cell therapy clinical trial in 2021. In terms of laboratory and production facilities, including equipment and instruments, Immuneel’s integrated facility is among the best in the world. This helps physicians and scientists to work together seamlessly both internally and with research institutes across the world on product creation and distribution. To support this target, the organisation has attracted exceptional global talent with prior experience in cell therapy, as well as a distinguished Scientific Advisory Board consisting of the field’s most respected scientific and intellectual giants.
These therapies are labour intensive, meticulously managed, require costly reagents/consumables, and are difficult to automate. The logistics of preserving and transporting cryopreserved cells continues to be a global problem. Because of all of these factors, cell therapies are exceedingly difficult to produce and supply, and thus are extremely costly. Cell therapies are difficult to prescribe clinically, and patients must be closely monitored for adverse events in the hospital immediately after infusion.
What is CAR T-Cell therapy (Chimeric antigen receptors)?
CAR T-Cell therapy is a form of immunotherapy that uses specially modified T-cells which are part of our immune system to fight cancer. A sample of patients T cells are collected from the blood, then it is modified to produce special structures called chimeric antigen receptors (CAR) on their surface. When these modified CAR cells are reinfused in the patient, these new cells attack the specific antigen and kills the tumor cells.
Is CAR T-Cell therapy a type of immunotherapy?
Yes, CAR T-Cell therapy is a type of immunotherapy treatment. IMMUNOTHERAPY is a ground-breaking method of treating cancer that has enormous potential. Because they can hide from our immune systems, cancer cells thrive in our bodies. Some medications, such as immunotherapies, can either mark cancer cells to make it simpler for the immune system to locate and eliminate them or strengthen our immune system so it can fight cancer more effectively. Immunotherapy for cancer treatment in India is available and lot of papers have been presented by various researchers on right dosing of immunotherapy.
Adaptive cell therapy
This therapy is also called as adaptive cell therapy A type of immunotherapy in which T cells (a type of immune cell) are given to a patient to help the body fight diseases, such as cancer. In cancer therapy, T cells are usually taken from the patient’s own blood or tumor tissue, grown in large numbers in the laboratory, and then given back to the patient to help the immune system fight the cancer. Sometimes, the T cells are changed in the laboratory to make them better able to target the patient’s cancer cells and kill them. Types of adoptive cell therapy include chimeric antigen receptor T-cell (CAR T-cell) therapy and tumor-infiltrating lymphocyte (TIL) therapy. Adoptive cell therapy that uses T cells from a donor is being studied in the treatment of some types of cancer and some infections. Also called adoptive cell transfer, cellular adoptive immunotherapy, and T-cell transfer therapy.
What type of cancers does CAR T-cell therapy treat ?
Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, multiple myeloma, and B-cell acute lymphoblastic leukaemia (ALL) in paediatric and young adult patients up to the age of 25 are approved to be treated using CAR T-cell therapy. Clinical trials are ongoing for other types of blood cancers & solid tumors.
How does CAR T-Cell therapy work?
CAR T-cell therapy takes help from body’s own immune system to attack and kill cancer cells. This is done by removing some specified cells from the blood of the patient, modifying them in the lab and re-injecting them into the patient. CAR T-cell therapy has produced very encouraging results in Non-Hodgkin lymphoma and thus approved by FDA.
You may like to read: Car T-Cell therapy in China
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CAR T-Cell therapy is currently available in some leading cancer institutes in USA, UK, China, Singapore, South-Korea, Malaysia and Israel.
CAR T-cell therapy approved by FDA
Till date FDA has approved following CAR T-cell therapies:
- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)
Who are the right candidates for CAR T-Cell therapy ?
At present FDA has approved CAR T-Cell therapy for some forms of aggressive and refractory Non-Hodgkin lymphoma and relapsed and refractory acute lymphoblastic leukemia. Patient need to send full medical reports to ascertain the use of CAR T-Cell therapy for his treatment.
Inclusion criteria for CAR T-cell therapy :
1. Patients with CD19+ B-cell Lymphoma(At least 2 prior combination chemotherapy regimens)
2. To be aged 3 to 75 years
3. ECOG score ≤2
4. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
Exclusion criteria for CAR T-cell therapy :
1. Intracranial hypertension or unconsciousness
2. Respiratory failure
3. Disseminated intravascular coagulation
4. Hematosepsis or Uncontrolled active infection
5. Uncontrolled diabetes.
Advantages of CAR T-Cell therapy
- >5000 CAR T cases done by highly skilled doctor’s.
- Hospitals in China has developed more CAR T Cell types including CD19 & CD 22 then any other country in the world.
- China is conducting more than 300 clinical trials on CAR T Cell therapy. More than any other country on the planet.
- Clinical effect of CAR T Cell is similar to that in USA or any other country and sometimes better.
Treatment process for CAR T-Cell therapy
- Complete evaluation of the patient
- T-cell collection from the body
- T-cells are then engineered in the lab
- Genetically engineered T-Cells are then multiplied by using growing them in the laboratory. These cells are frozen and then sent to the treating centres.
- Prior to infusing, patient may be given chemotherapy for their cancer. This helps the therapy work in a better way.
- Soon after chemotherapy CAR T-Cells are infused by a process which is similar to blood infusion.
- There is a 2-3 month of recovery period for the patient.
Time frame for CAR T-Cell therapy
1. Examination & test: one week
2. Pre-treatment & T-Cell Collection: one week
3. T-Cell preparation & return: two-three weeks
4. 1st Effectiveness analysis: three weeks
5. 2nd Effectiveness analysis: three weeks.
Side effects of CAR T-Cell therapy
The common side effects of CAR T-cell therapy include:
- Cytokine release syndrome
In some cases, patients may develop flu-like symptoms such as fever, chills, headache, nausea, vomiting, loose stools, and muscle or joint pains. It may also cause low blood pressure, difficulty in breathing, and a fast heart rate. These side effects are due to the release of cytokines by the immune cells during CAR T-cell therapy. These symptoms are usually mild, but can be serious and life threatening in some patients. - Neurological events
Neurological events can occur and can be serious in some patients. Such events include encephalopathy (brain injury and malfunction), confusion, difficulty speaking, agitation, seizures, drowsiness, altered state of consciousness and loss of balance. - Neutropaenia and Anaemia
Some patients may develop neutropenia or low white cell count. Similarly, anaemia or low red blood cell count may also occur due to this therapy.
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Fortunately, most of these side effects usually resolve on their own or can be managed with the use of medications.
How effective is CAR T-Cell therapy ?
CAR T-cell therapy for the treatment of lymphoma and other blood cancers has shown promising outcomes. Since CAR T-cell treatment, many patients who had previously relapsed blood tumour’s had promising results and no evidence of cancer. It has also aided in the rehabilitation of patients who have previously failed to respond to most traditional cancer therapies.
However, longer-term studies for a larger patient population are needed to validate the efficacy of this treatment. Large-scale experiments would also aid in determining the likelihood of side effects and the right ways to deal with them.
Clinical trials in CAR T-Cell therapy
There are more than 1500 clinical trials taking place across the globe in top cancer hospitals. Half of these clinical trials are ongoing in China only. In India 4 companies are currently doing trials on their CAR-T Cells.
Cost of CAR T Cell therapy in different countries
Approximate cost of CAR T cell therapy is different countries is given below :
USA – $ 500,000 – $ 700,000 USD
UK – $ 400,000 – $ 500,000 USD
Israel – $ 80,000 – $ 100,000 USD
Singapore – $ 400,000 – $ 500,000 USD
Korea – $ 400,000 – $ 500,000 USD
Japan – $ 500,000 – $ 700,000 USD
China – $ 10,000 – $ 70,000 USD
Malaysia – $ 50,000 – $ 65000 USD
(* CAR T-Cell therapy is approved for solid tumors and cancers in China).
Cost of CAR T-Cell therapy for solid cancers is around $ 40,000 USD in China and $ 50,000 USD in Malaysia.
