Health Matters | 9-Year-Old Ishwari is Now Cancer-Free. Therapy That Saved Her May Hit the Market by Year-End

Despite her lack of interest in academics, Ishwari’s parents and teachers aren’t fazed. Her life has never been the same as most other children her age. At the age of six, she was diagnosed with acute lymphocytic leukaemia (ALL), a type of cancer of the blood and bone marrow.

Despite undergoing several rounds of painful chemotherapy at Tata Memorial Centre in Mumbai, the cancer kept coming back. Even after surviving the long and painful treatment, it relapsed. But Ishwari’s story took a remarkable turn with CAR-T cell therapy.

A resident of Nashik, Ishwari became one of the first participants in a paediatric trial for CAR-T cell therapy, a ground-breaking treatment for certain types of cancer. Miraculously, in the initial phase of the trial, Ishwari was declared cancer-free, defying the odds.

“My wife and I were devastated (when she was diagnosed). Our daughter was dying anyway, so we decided to give her one chance through this trial,” Bagirav, Ishwari’s father, who is a local car driver, told News18 over phone.

According to Ishwari’s healthcare provider, Dr Gaurav Narula, project lead of CAR-T and Cell Therapy Centre, Tata Memorial Centre: “It’s been around 1.5 years and Ishwari is in complete remission mode, which means she is cancer-free now.”

Ishwari’s father told News18 that now she eats well and is as active as any other child. “She plays and attends school regularly. However, we continue to follow up with check-ups and blood tests,” her father said, reflecting on the time when Ishwari’s survival seemed uncertain.

“I still recall those days when my wife and I would cry all day. It felt like a curse, but we are grateful we took a chance with CAR-T therapy.”

Ishwari’s journey symbolises hope for countless children battling life-threatening cancers. Her resilience and the potential success of the therapy offer a ray of hope for a brighter, cancer-free future for young warriors like her.

“The ongoing paediatric trial awaits the conclusion of the second phase by the end of this year. The commercial approval for paediatric use of the therapy is expected to come later this year,” said Narula who is also a professor of paediatric oncology and health sciences at Tata Memorial Centre.

“Acute lymphocytic leukaemia is one of the most common cancers among children. There are many more children like Ishwari in the trial who have witnessed extremely encouraging results.”

The clinical trials are being done by Narula and his team from Tata Memorial Centre.

Chimeric Antigen Receptor (CAR) T-cell therapy or CAR-T cell therapy is a “first in India” gene therapy which is in the second phase of the pilot clinical trial for children. It has already been rolled out commercially for adults, which means that private hospitals can now buy the therapy for their patients. So far, out of 15 commercial patients, three patients have already witnessed cancer remission.

How Does CAR-T Work?

In India, the challenge of cancer is escalating into a significant public health issue. Recent estimates indicate a sharp rise in new cancer cases, reaching nearly 16 lakh in 2023 compared to around 9.80 lakh in 2010. Tragically, approximately 8 lakh individuals lose their lives to cancer annually, and this figure is projected to increase significantly in the years ahead.

In India, nearly more than 50,000 new childhood cancer cases occur every year.

Tata Memorial Centre, which is amongst the oldest and largest cancer centres in the world, registers more than 2,500 cancer patients every year, aged 0 to 15 years. Out of these patients, around 1,000 suffer from blood cancer.

Under the therapy, blood is drawn from the patient’s body. Doctors then remove a special type of white blood cell called ‘T-cells’ from the blood. These T-cells are programmed in a lab to recognise and attack cancer cells in the body of the patient. These cells are manufactured in GMP-certified manufacturing units and are finally put back into the patient’s body.

“As soon as these cells find cancer cells in the body, they start multiplying and attack cancer cells. It’s an army of cells trained to kill the cancer cells inside the body,” Narula explained. “This is the living drug programmed to eliminate cancerous cells.”

Journey of Domestic CAR-T Versus Global Therapies

In 2017, the US health regulator approved CAR-T for adults. The therapy was priced at $450,000 – around Rs 3.73 crore when converted using the latest dollar rate. The technology is also available in several other developed countries, including in Europe and China.

However, when imported for patients in India, the price is much higher, as it would include hospitalisation charges, doctor and administration feed and other costs, which is unaffordable for the majority of Indians.

“China also has the technology. However, patients need to fly down to the country for the entire course of therapy,” Narula said, adding that Indian technology has brought down the cost below Rs 50 lakh. “It is available for around Rs 42 to Rs 45 lakh.”

In June 2021, India started the clinical trial to develop domestic CAR-T for adults. Launched as a collaboration led by Narula from Tata Memorial Centre and Dr Rahul Purwar, Professor of Biosciences at IIT-Mumbai, the trial entered Phase 2 in December 2022 and received commercial approvals in October 2023. The trials were financially supported by the central government’s Department of Biotechnology (DBT)- National Biopharma Mission along with ImmunoACT, a spin-off company affiliated with IIT-Mumbai.

The approval stemmed from the outcomes of two small-scale clinical trials conducted within India, involving 64 individuals diagnosed with advanced lymphoma or leukaemia. Results presented in December 2023 at the American Society of Hematology meeting revealed that 67% of patients (36 out of 53) in the combined trials experienced a significant reduction in cancer severity (objective response), with half of them achieving complete remission.

Out of the 53 participants, none experienced the neurological side effects commonly associated with CAR T-cell therapies approved in the United States. Additionally, only a small fraction (5%) encountered severe immune-related side effects.

Evolving Tech

According to Narula, CAR-T is presently approved for the treatment of B-cell lymphomas and leukaemia. “Right now, CAR-T is proven efficient in treating B-cell malignancies. However, in the coming years, it could be used for the treatment of solid tumours, neuroblastoma and other type of blood cancers.”

“Also, we need to understand why there are some patients who do not respond to the therapy,” he said, adding that while currently the therapy has not demonstrated significant side effects, going forward, insight into its long-term effects shall be gained.

CAR-T therapy offers a ray of hope to individuals like Ishwari and those who may have lost hope for survival. In the years ahead, it has the potential to aid the global fight against the devastating disease known as cancer.