NexCAR19™ is an autologous CAR-T cell therapy indicated for the treatment of patients with relapsed or refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL) who have not responded to, or have relapsed following, standard lines of therapy
NexCAR19™
A New Hope for Hard to Treat B-Cell Cancers
Patients
HCP
What is NexCAR19™ ?
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, and 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:
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Patient is clinically stable and fit for leukapheresis
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Appropriate drug washout periods are observed
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Any bridging therapy is planned with manufacturing timelines in mind
Step 3: LSM Collection
Timely & Controlled Pickup of Leukapheresis Material
Upon successful leukapheresis:
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ImmunoACT or its certified logistics partner will coordinate fresh refrigerated pickup of the Leukapheresis Starting Material (LSM)
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Ensuring correct labeling, documentation, and chain-of-custody protocols are followed
Step 4: Manufacturing
Stay Informed at Key Checkpoints During Manufacturing
You will receive notifications at the following stages:
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LSM acceptance and initiation of manufacturing
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Completion of in-process and final quality checks
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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:
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Confirm patient’s fitness for lymphodepletion and infusion
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Administer NexCAR19 as per prescribing information
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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
📋 B-ALL Specific Criteria
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Low percentage of blasts in:
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Peripheral blood
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Bone marrow
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Presence or absence of extramedullary disease
📋 B-NHL Specific Criteria
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Low disease bulk:
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Subjective quantification by nodal size & extent of nodal/extranodal involvement
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Or metabolically active tumor volume
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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
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™ 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.
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.
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
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.
