NexCAR19™

A New Hope for Hard to Treat B-Cell Cancers

An Overview of NexCAR19™

A breakthrough in precision oncology, NexCAR19™ (Talicabtagene autoleucel) is a second-generation, autologous, CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy. Built on a fully humanized molecular platform, it is precision-engineered to address the critical unmet need in relapsed or refractory B-cell malignancies.

NexCAR19™ is a prescription therapy indicated for specific relapsed or refractory B-cell Non-Hodgkin’s Lymphomas and B-cell Acute Lymphoblastic Leukaemia in patients whose frontline or other standard treatments have been unsuccessful.

INN
Talicabtagene autoleucel
Type
Autologous CAR-T cell therapy
Target
CD19-directed
Generation
Second-generation
Indication
Relapsed/refractory B-cell cancers
Eligibility
Age 15+ · ≥1 prior line
72%
B-NHL
Response Rate
Overall Response Rate
73%
B-ALL
Response Rate
Overall Response Rate
3+
Years
Longest Remission
Duration of Response
98%
Manufacturing
Success Rate
Commercial batches
~18 Days
Vein-to-Vein
Turnaround
Fastest in class (India)

Which cancers can NexCAR19™ treat?

NexCAR19™ is for patients with challenging B-cell cancers, which are often inadequate to treat with chemoimmunotherapy.

Diffuse Large B-cell Lymphoma (DLBCL)
Most common aggressive B-cell lymphoma type.
Primary Mediastinal B-cell Lymphoma (PMBCL)
A rare chest-based lymphoma in younger adults.
Follicular Lymphoma (FL)
Slow-growing with potential to transform aggressively.
Mantle Cell Lymphoma (MCL)
Rare subtype often diagnosed late and challenging.
Marginal Zone Lymphoma (MZL)
Associated with inflammation or infection origins.
High-Grade B-cell Lymphoma
Rapid progression, requires fast-acting therapies.
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Aggressive leukemia impacting bone marrow and blood.

Patient Journey Overview

Step 1: Eligibility Assessment

Determine Suitability for NexCAR19™ Therapy

Evaluate the patient against NexCAR19’s eligibility criteria, including:

  • Diagnosis
  • Disease status
  • Prior lines of therapy
  • Performance status

Step 2: Slot Scheduling

Coordinate Leukapheresis Timing Based on Clinical Readiness

Once eligibility is confirmed, our team will contact you to schedule a leukapheresis slot at your facility or designated center.

Please ensure:

  • Patient is clinically stable and fit for leukapheresis
  • Appropriate drug washout periods are observed, and any bridging therapy is planned with manufacturing timelines in mind

Step 3: LSM Collection

Timely & Controlled Pickup of Leukapheresis Material

Upon successful leukapheresis:

  • ImmunoACT or its certified logistics partner will coordinate fresh, refrigerated pickup of the Leukapheresis Starting Material (LSM).
  • Proper labeling, documentation, and chain-of-custody protocols will be strictly followed to ensure compliance and traceability.

Step 4: Manufacturing

Stay Informed at Key Checkpoints During Manufacturing

You will receive notifications at the following stages:

  • LSM acceptance and initiation of manufacturing
  • Completion of in-process and final quality checks
  • Expected product readiness and dispatch timeline

Step 5: Infusion & Monitoring

Product Delivery, Infusion Scheduling, and Post-Infusion Care

NexCAR19™ will be delivered in advance of your selected infusion window:

  • Confirm patient’s fitness for lymphodepletion and infusion
  • Administer NexCAR19™ as per prescribing information
  • Follow structured monitoring protocol post-infusion, including CRS/ICANS management if needed
Become a Partner

Unmet Needs in Relapsed/Refractory B-Cell Malignancies

Transforming outcomes for patients with relapsed/refractory B-cell malignancies—where current treatments fall short

~100,000

Annual Estimated Diagnosed Cases of B-ALL & DLBCL in India

~40%

Relapses in patients with DLBCL, of which 10% have refractory disease

> 60%

Patients requiring a Stem Cell Transplant are unable to receive one.

~41%

Historical survival rate in patients with B-ALL

Patient Journey Overview

Determine Suitability for NexCAR19 Therapy

Evaluate the patient against NexCAR19’s eligibility criteria, including diagnosis, disease status, prior lines of therapy, and performance status.

Coordinate Leukapheresis Timing Based on Clinical Readiness

Once eligibility is confirmed, our team will contact you to schedule a leukapheresis slot at your facility or designated center.
Please ensure:

  • Patient is clinically stable and fit for leukapheresis

  • Appropriate drug washout periods are observed

  • Any bridging therapy is planned with manufacturing timelines in mind

Timely & Controlled Pickup of Leukapheresis Material

Upon successful leukapheresis:

  • ImmunoACT or its certified logistics partner will coordinate fresh refrigerated pickup of the Leukapheresis Starting Material (LSM)

  • Ensuring correct labeling, documentation, and chain-of-custody protocols are followed

Stay Informed at Key Checkpoints During Manufacturing

You will receive notifications at the following stages:

  • LSM acceptance and initiation of manufacturing

  • Completion of in-process and final quality checks

  • Expected product readiness and dispatch timeline

Product Delivery, Infusion Scheduling, and Post-Infusion Care

NexCAR19 will be delivered in advance of your selected infusion window:

  • Confirm patient’s fitness for lymphodepletion and infusion

  • Administer NexCAR19 as per prescribing information

  • Follow structured monitoring protocol post-infusion, including CRS/ICANS management if needed

What are the Side Effects of NexCAR19?

NexCAR19™ may cause side effects that are severe and/or life-threatening.

Fever (100.4°F/38°C or higher)
Difficulty breathing
Chills or shaking chills
Confusion
Dizziness or lightheadedness
Severe nausea, vomiting, or diarrhea
Fast or irregular heartbeat
Severe fatigue or weakness

Unmet Needs in Relapsed/Refractory B-Cell Malignancies

Transforming outcomes for patients with relapsed/refractory B-cell malignancies—where current treatments fall short

~100,000

Annual Estimated Diagnosed Cases of B-ALL & DLBCL in India

~40%

Relapses in patients with DLBCL, of which 10% have refractory disease

> 60%

Patients requiring a Stem Cell Transplant are unable to receive one.

~41%

Historical survival rate in patients with B-ALL

Consider NexCAR19™ as a treatment option

The administration of NexCAR19™ (Talicabtagene autoleucel) should be preceded by a thorough clinical risk evaluation and mitigation process at the treatment center. ImmunoACT recommends the following parameters as prerequisites for consideration of NexCAR19 for your patient. These parameters may be required by your patient’s insurer or payer towards their access to CAR-T cell therapy.

B-cell Non-Hodgkin’s Lymphomas (B-NHL)

  • Diffuse Large B-cell Lymphoma
  • High-grade B-cell Lymphoma, not otherwise specified
  • Primary Mediastinal Large B-cell Lymphoma
  • Follicular Lymphoma
  • Transformed Follicular Lymphoma (tFL)
  • Mantle Cell Lymphoma (specify pleomorphic or blastoid)

Confirmed by Immunohistochemistry & Histopathology/Biopsy Reports

B-cell Acute Lymphoblastic Leukaemia (B-ALL)

  • Ph+ve B-ALL or Ph-like B-ALL or Not Otherwise Specified
  • CD19+ve expression (dim/moderate/bright) on the malignant clone, and absence of a CD19-ve malignant clone 

Confirmed by Bone Marrow Aspiration and Biopsy through Flow Cytometry / Immunophenotyping

Approved in patients aged 15 and above, for the treatment of relapsed/refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia in India

NexCAR19™ was assessed in an open-label, multicentre, phase 1/2 study in six tertiary cancer centres across India. Of 64 patients aged 15 and above with either relapsed/refractor B-cell lymphoma or B-cell acute lymphoblastic leukaemia, 14 were enrolled in Phase 1, and 50 were enrolled in Phase 2. At an efficacy dose of at least 5 × 10⁶ CAR T cells per kg, NexCAR19 demonstrated an overall response rate of 73%. The trial exhibited a manageable safety profile with high efficacy in a difficult-to-treat population with B-cell malignancies, with these results published in Lancet Haematology

Recommended Pointers for Eligibility

  • ECOG: 0–2
  • Ejection Fraction (EF) on 2D Echo ≥ 45%
  • Peripheral Blood ALC ≥ 500/μL or Absolute CD3+ T cell count ≥ 150/μL
  • AST/ALT ≤ 3× ULN, Total Bilirubin ≤ 2× ULN (Child-Pugh A/B unless derangement due to malignancy)
  • Creatinine Clearance ≥ 30 mL/min
  • Well-preserved lung function
  • Well-controlled pre-existing medical & surgical comorbidities
  • Absence of active infection or acute inflammation
  • CNS disease well-mitigated (if involved)
  • Viral Marker Negative Status: HIV, HBV, HCV, CMV

  • Low percentage of blasts in:

    • Peripheral blood

    • Bone marrow

  • Presence or absence of extramedullary disease

  • Low disease bulk:

    • Subjective quantification by nodal size & extent of nodal/extranodal involvement

    • Or metabolically active tumor volume

  • LDH levels may be used as additional supporting marker

How does NexCAR19™ work?

NexCAR19™ utilizes precisely engineered Chimeric Antigen Receptors featuring:

  • A humanized single-chain variable fragment (ScFv) antibody that specifically targets CD19 markers found on B-cells
  • An optimized flexible spacer that enhances target binding efficiency and cellular interaction
  • A specialized 4-1BB co-stimulatory domain that significantly boosts T-cell activation, promotes robust proliferation, and supports long-term persistence
  • CD3ζ signaling components that trigger potent T-cell immune responses upon cancer cell recognition
NexCAR19 Working

Proven Clinical Performance

Our anti-CD19 binding technology has demonstrated remarkable persistence in clinical settings, with documented durability of action extending beyond 24 months in select patients. The humanized ScFv component delivers exceptional efficacy while contributing to a reduced incidence of severe treatment-related toxicities.

Superior Therapeutic Profile

NexCAR19™ modified T-cells offer a comprehensive treatment solution:

  • Safety: Rigorously tested cellular product with established safety profile
  • Durability: Long-lasting anti-cancer activity for sustained disease control
  • Effectiveness: Consistent response rates across diverse patient populations

Optimized Dosing Strategy

With an efficacy threshold of more than 5 million CAR-T cells per kilogram of body weight, NexCAR19™ achieves exceptional tumor penetration and maintains effectiveness even in challenging high-risk patient populations.

NexCAR19™ is a type of CAR-T cell therapy. T-cells are naturally made by your body as an advanced defense against viruses and cancer cells. As they mature, they develop specific connectors (receptors) to target key signals in cancer cells. However, cancers can escape the inbuilt defense mechanism of T-cells, which can lead to an increase in tumor burden and can result in the survival of cancer cells and a further increase in tumor burden. CD19 is a protein commonly present on the surfaces of certain B-cell cancers.

Our scientists have designed instructions for your T-cells to express unique proteins called Chimeric Antigen Receptors (CARs) on their surface, which will enable them to bind to a specific target on the cancer cells. These instructions are delivered genetically using a vehicle known as a lentiviral vector.NexCAR19 targets a marker called CD19, which is commonly present on the surface of cancerous B-cells.

1. Isolate

Select and activate T-cells from the patient’s blood sample.

2. Program

Deliver genetic instructions to T-cells using viral vectors.

3. Engineer

Enable T-cells to express Chimeric Antigen Receptors (CARs).

4. Expand

Multiply CAR-T cells to achieve the therapeutic dose.

5. Infuse

Administer CAR-T cells to the patient for targeted cancer treatment.

Smarter CAR-Construct & Design for Safer Treatment

At the heart of ImmunoACT’s innovation is a next-generation cell and gene therapy platform, purpose-built to deliver affordable efficacy without compromising safety. Our approach blends cutting-edge science with thoughtful design to make these therapies more accessible and tolerable. 

Our CAR-T constructs use fully humanized components, making them more “familiar” to the immune system. This reduces the risk of rejection, minimizes off-target toxicity, and improves patient experience by lowering the need for intensive supportive care.

Each CAR we design includes:

  • A single-chain variable fragment (scFv) tailored for precise tumor targeting
  • A flexible hinge (spacer) to enable optimal antigen engagement
  • A CD8α transmembrane domain for enhanced stability
  • A 4-1BB co-stimulatory domain to support T-cell survival and sustained action
  • A CD3ζ signaling domain to trigger strong and specific immune responses

Our CAR-T therapies integrate humanized sequences and undergo rigorous optimization to ensure potency, persistence, and safety. By reducing the likelihood of severe toxicities, we are not just improving patient safety, we are redefining how cell therapies can be delivered.

The gene sequence of the CAR construct is first integrated into a plasmid, which is then used to produce a lentiviral vector. This vector delivers the CAR gene into T cells, enabling them to recognize and attack cancer cells.

NexCAR19™ Manufacturing Process

1. Leukapheresis

Peripheral Blood Mononuclear Cells (PBMCs) are collected from the patient using leukapheresis.
This forms the foundational starting material for autologous CAR-T cell manufacturing.

2. Monocyte Depletion

Monocytes are removed from the PBMC population to reduce non-T-cell components.
This enhances T-cell purity and improves the efficiency of downstream processes.

3. T-Cell Activation

T-lymphocytes are activated using CD3/CD28 costimulatory signals in a controlled environment. This primes the cells for efficient gene transfer during the transduction step.

4: Lentiviral Transduction

Activated T-cells are genetically modified with a lentiviral vector encoding the anti-CD19 CAR. This step equips T-cells to recognize and attack CD19-expressing tumor cells.

5: CAR-T Cell Production

Following transduction, T-cells begin expressing the chimeric antigen receptor on their surface. These cells are now classified as NexCAR19—genetically reprogrammed to target B-cell malignancies.

6: Expansion to Target Dose

The CAR-T cells are cultured under GMP conditions to reach the therapeutic dose. Cell growth is monitored to maintain viability, potency, and phenotype consistency.

7: Formulation & Cryopreservation

The final CAR-T product is formulated with infusion-ready buffer and cryopreserved. Post quality checks, it is stored under ultra-low temperatures until patient infusion.

Why NexCAR19™ ?

NexCAR19™ demonstrates strong clinical efficacy with rapid response rates, durable remissions, and a streamlined manufacturing timeline – addressing critical unmet needs in relapsed/refractory B-cell malignancies.

600+
Total Patients Treated
Clinical & Commercial
72%
B-NHL Response Rate
Day 28 clinical response
73%
B-ALL Response Rate
Day 28 clinical response
>50%
1-Year Survival
B-NHL & B-ALL patients
~18
Vein-to-Vein Time
Days in clinical trials
3+
Longest Remission
Years sustained response
<15
Hospitalization
Days post infusion
Data sourced from NexCAR19™ Phase I/II clinical trials (NCT04049513). Published: The Lancet Haematology, April 2025; Blood Cancer Journal, April 2025. Individual patient outcomes may vary. Last updated February 2026.

Safety & Efficacy Highlights

B-ALL

73% Complete Response Rate in Adult & Adolescent

1 Year PFS with BM Blasts < 25%

1 Year OS with BM Blasts < 25%

B-NHL

72% Overall Response Rate

1 Year PFS with MB Volume < 100 cubic cm

1 Year OS with MB Volume < 100 cubic cm

Treatment Process

A comprehensive guide through each step of your NexCAR19 treatment journey, detailing what to expect and how to prepare ?

Step 1: Initial Consultation

Meet with your hematologist or oncologist to discuss NexCAR19 treatment and evaluate your eligibility for CAR T-cell therapy.

 

What to Expect:
  • Comprehensive medical assessments, including blood tests and imaging studies.
  • Discussion of your medical history and previous treatments.
  • Explanation of the CAR T-cell therapy process, potential benefits and risks.
Preparation Tips:
  • Bring a list of current medications and any relevant medical records.
  • Prepare questions or concerns to discuss with your healthcare team.

Step 2: T-Cell Collection (Leukapheresis)

Collect your T-cells, a type of white blood cell, for modification

 

What to Expect:
  • Outpatient procedure lasting approximately 3-6 hours
  • Blood is drawn from a vein, passed through a machine to extract T-cells, and the remaining blood is returned to your body.
Preparation Tips:
  • Stay well-hydrated and eat a healthy meal before the procedure
  • Wear comfortable clothing with sleeves that can be easily rolled up.
  • Bring entertainment (e.g., books, music) to pass the time

Step 3: Manufacturing of NexCAR19 Cells 

Genetically modify your collected T-cells to recognize and attack cancer cells

 

What to Expect:
  • Your T-cells are sent to a specialized laboratory for modification, a process that typically takes 2-3 weeks
  • During this period, your healthcare team will monitor your condition and may administer treatments to manage your disease
Preparation Tips:
  • Maintain open communication with your healthcare team and report any new symptoms
  • Plan for logistical needs, such as transportation and lodging, if the treatment center is far from home.

Step 4: Bridging Therapy (If Necessary) 

Control disease progression while awaiting the return of your modified T-cells.

What to Expect:
  • Administration of additional cancer treatments, such as chemotherapy or radiation, as determined by your healthcare team.
Preparation Tips:
  • Discuss potential side effects and management strategies with your healthcare team.
  • Ensure you have support at home to assist with any treatment-related needs

Step 5: NexCAR19 Infusion

Reintroduce the genetically modified T-cells into your body to target and eliminate cancer cells.

What to Expect:
  • The infusion is a one-time procedure lasting approximately 30 minutes. 
  • Administered in a hospital setting with close monitoring
  • You may be required to stay in the hospital for at least 7 days post-infusion for observation
Preparation Tips:
  • Pack a hospital bag with essentials, including comfortable clothing and personal items.
  • Arrange for a caregiver or family member to be present for support

Step 6: Post-Infusion Monitoring and Recovery

Ensure your safety and manage any side effects following the infusion.

What to Expect:
  • Regular follow-up appointments to monitor your progress and address any concerns
  • Be vigilant for potential side effects, such as fever, fatigue, or neurological symptoms, and report them immediately.
Preparation Tips
  • Keep a journal of any symptoms or side effects to share with your healthcare team.
  • Have a support system in place to assist with daily activities as needed.

NexCAR19™ Prescribing Information Guide

Essential prescribing information and medication guide for NexCAR19™ (Acetalycabtagene autoleucel), a CAR-T cell therapy for treating relapsed/refractory B-cell lymphomas and B-cell acute lymphoblastic leukemia. Includes detailed dosing instructions, safety information, and patient counseling guidelines.

Download Prescribing Information PDF

Partnered Hospitals

Our strong association with over 80 leading cancer treatment hospitals in India ensures hassle-free treatment with our CAR-T cell therapies.

Find A Treatment Centre Near You
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