WHAT IS
NEXCAR19?
NexCAR19 is India's first home-grown CAR-T cell therapy โ CDSCO-approved, clinically validated, and priced at a fraction of Western alternatives. Here is everything patients and families need to know.
analyticsAt a Glance
- check_circleDeveloped by ImmunoACT (IIT Bombay + Tata Memorial Centre Mumbai)
- check_circleCDSCO approved October 2023 โ first Indian-developed CAR-T product
- check_circleCost ~$30,000โ40,000 USD vs $475,000 in the USA
- check_circle73% complete remission rate in pivotal Nature Medicine 2024 trial
What Is NexCAR19?
NexCAR19 is a CD19-directed CAR-T cell therapy developed entirely in India. It targets the CD19 antigen found on the surface of malignant B-cells, reprogramming a patient's own T-cells to find and destroy cancer.
โNexCAR19 is not a cheaper copy โ it is an independently developed, clinically validated CAR-T product that achieved efficacy comparable to Western approvals at 12x lower cost.โ
ImmunoACT โ IIT Bombay + Tata Memorial Centre
ImmunoACT was founded in 2018 as a spin-off from Prof. Rahul Purwar's laboratory at IIT Bombay, in collaboration with the BMT unit at Tata Memorial Centre Mumbai. It is the first biotech company to bring a fully Indian-developed CAR-T product to market.
CD19-Targeting Mechanism
NexCAR19 uses an autologous (patient's own) T-cell product engineered with a second-generation CAR construct targeting CD19. CD19 is expressed on B-cells from early development through maturation, making it an ideal target for B-cell malignancies.
CDSCO Approved โ October 2023
NexCAR19 received marketing approval from India's Central Drugs Standard Control Organisation (CDSCO) in October 2023 โ making it the world's first approved CAR-T product developed outside of the USA, Europe, or China.
Approved Indications
NexCAR19 is approved for relapsed/refractory B-cell Acute Lymphoblastic Leukaemia (B-ALL) in both paediatric and adult patients, and for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) in adults after two or more prior lines of therapy.
NexCAR19 at a Glance โ Key Numbers
From the pivotal Nature Medicine 2024 publication and CDSCO approval data.
- 73%Overall CR RateComplete remission in the pivotal 33-patient trial across B-ALL and DLBCL.
- $30โ40KApprox. Cost USDManufacturing + therapy cost in India, compared to $475,000 in the United States.
- 3โ4 WeeksManufacturing TimeLeukapheresis to infusion-ready product โ comparable to Western timelines.
- 6%Grade 3+ CRSSevere cytokine release syndrome rate โ significantly lower than comparable Western products.
Clinical Efficacy: NexCAR19 Pivotal Trial Results
Nature Medicine 2024 publication โ 33 heavily pre-treated patients (median 3 prior lines), both B-ALL and DLBCL cohorts.
Complete Remission Rates
- Overall CR73%
- B-ALL CR81%
- DLBCL CR58%
CRS Safety Profile
- Any Grade CRS52%
- Grade 3+ CRS6%
- Any Grade ICANS15%
How to Access NexCAR19 in India
For international patients, accessing NexCAR19 requires coordinating evaluation, apheresis, manufacturing, and infusion at an approved Indian centre. CancerFax manages this end-to-end.
- 1
Submit Medical Records
Share diagnosis, pathology, prior treatment history, and recent imaging with CancerFax for eligibility pre-screening.
- 2
Eligibility Confirmation
Oncology team at the treating centre (e.g., Tata Memorial) confirms CD19+ disease, ECOG status, organ function, and absence of active CNS disease.
- 3
Travel & Leukapheresis
Patient travels to India. Leukapheresis (T-cell collection) is performed as a day procedure โ 3โ5 hours. Patient may return home or remain in India during manufacturing.
- 4
CAR-T Manufacturing
T-cells are engineered at the ImmunoACT facility. NexCAR19 has a manufacturing success rate >95%.
- 5
Lymphodepletion + Infusion
Patient returns to India for lymphodepletion chemotherapy (fludarabine + cyclophosphamide, 3 days), followed by NexCAR19 infusion.
- 6
In-Hospital Monitoring
14โ28 days inpatient for CRS and ICANS surveillance. Tocilizumab biosimilar available on-site for CRS management.
Why NexCAR19 Is Significant for Global Cancer Access
NexCAR19 represents a proof-of-concept for the entire low-and-middle-income country (LMIC) biotech model โ that world-class cell therapy can be developed, manufactured, and delivered affordably.
Proof of Concept for Emerging Market CAR-T
Before NexCAR19, CAR-T was effectively inaccessible to the 85% of the global cancer burden in low-and-middle-income countries. NexCAR19 demonstrated that a domestic academic-industry collaboration can produce an approved, effective therapy at a price most countries can consider.
From Lab Bench to Regulatory Approval in Under 7 Years
Prof. Rahul Purwar began the IIT Bombay CAR-T programme in approximately 2016. The first academic trial enrolled patients in 2021โ2022. Marketing approval was granted in October 2023 โ a timeline that rivals well-funded private biotech companies in the West.
More from the CAR-T India Resource Library
Continue exploring โ from the complete CAR-T India guide to NexCAR19 trial data, comparison with Kymriah, and disease-specific guides.
- CAR-T Cell Therapy in India โ Complete Guide
- IIT Bombay, Tata Memorial & ImmunoACT: How India Built Its Own CAR-T
- NexCAR19 Clinical Trial Results: What the Pivotal Data Shows
- NexCAR19 vs Kymriah in India: Full Comparison for Patients
- CAR-T for B-Cell ALL in India: Paediatric and Adult Programmes
- How to Access CAR-T Cell Therapy in India via CancerFax
Frequently Asked Questions About NexCAR19
Is NexCAR19 the same as Kymriah or Yescarta?
No. NexCAR19 is an independently developed CAR-T product, not a licensed copy or biosimilar of Kymriah or Yescarta. It uses a distinct CAR construct developed at IIT Bombay. However, like those therapies, it targets CD19 and uses autologous T-cells. Its efficacy in B-ALL (81% CR) is comparable to Kymriah's ELIANA trial, though the datasets differ in patient population and follow-up duration.
Can international patients receive NexCAR19 in India?
Yes. NexCAR19 is available to international patients at approved centres including Tata Memorial Centre Mumbai. International patients require a medical visa for India. CancerFax coordinates the full pathway โ eligibility review, hospital liaison, leukapheresis scheduling, manufacturing, and infusion appointment โ along with accommodation and interpreter support where needed.
How is the $30,000โ40,000 cost broken down?
The cost typically covers the NexCAR19 manufacturing and product fee (the largest component), lymphodepletion chemotherapy (fludarabine + cyclophosphamide), and inpatient monitoring for 14โ28 days. It does not always include international flights, accommodation, bridging chemotherapy, or complications management. A full all-in estimate for international patients is typically $40,000โ55,000 USD depending on hospital, length of stay, and any complications.
What happens if NexCAR19 manufacturing fails?
ImmunoACT reports a manufacturing success rate >95%, meaning fewer than 1 in 20 products fail quality release. In the rare event of failure, the team typically attempts a second leukapheresis and re-manufacture. This is an important question to raise with your treating centre before committing to the treatment pathway.
Is NexCAR19 approved for multiple myeloma or other cancers?
No. As of 2024, NexCAR19 is approved in India only for relapsed/refractory B-ALL and relapsed/refractory DLBCL. Clinical trials are ongoing for additional CD19+ B-cell malignancies. Patients with other diagnoses should ask their oncologist whether an investigational trial is available, or contact CancerFax for an assessment of alternative options in India or China.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination โ travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
Is NexCAR19 Right for Your Case?
CancerFax reviews your medical records and coordinates NexCAR19 eligibility assessment at Tata Memorial Centre and other approved Indian centres โ including travel, logistics, and translation support.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified oncologist before making treatment decisions.