Description
Indication & Scope
Ciltacabtagene Autoleucel Injection treats adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy.
- Mechanism: Genetically modified autologous T cells target BCMA on malignant plasma cells, trigger targeted cytotoxicity to eliminate myeloma tumor cells.
- Drug class: Autologous CAR-T cell therapy, adoptive cellular immunotherapy, anti-myeloma biologic.
- Clinical use: Third-line and later definitive treatment for heavily pretreated multiple myeloma.
| Generic Name | Ciltacabtagene Autoleucel Injection |
| Brand Name | CARVYKTI |
| Ingredient | Ciltacabtagene Autoleucel Injection |
| Dosage Form | Injection |
| Package | 30ml*1 bag(Dose is 0.5×10^6 to 1.0×10^6 live CAR-positive T cells per kilogram of body weight) |
| Conditions Treated | Relapsed and refractory multiple myeloma |
| Taboos | 1. Active severe uncontrolled systemic infection
2. Uncontrolled severe autoimmune diseases 3. Known severe hypersensitivity to cell preparation components or excipients 4. Patients unfit for lymphodepleting chemotherapy 5. Pregnant or breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store in liquid nitrogen vapor phase at ≤ -150°C before infusion, avoid repeated freeze-thaw cycles |
| Manufacturer | ChuanQi Biotechnology Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20240038 |
| Approval Date | Aug 20, 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Individualized cell dose based on patient weight and leukapheresis cell count.
Time: Infusion is given 2 to 7 days after completion of lymphodepleting chemotherapy.
Instructions for use:
1. collect the patient’s autologous T cells via leukapheresis, followed by professional genetic modification and cell manufacturing in a qualified laboratory.
2. patients receive lymphodepletion chemotherapy to prepare the immune microenvironment, and the finished CAR-T cell product is finally administered to the patient through a single intravenous infusion.
Interaction: Immunosuppressants raise infection risk; live vaccines are prohibited during treatment and recovery period.
Side effects: Cytokine Release Syndrome (CRS), ICANS neurotoxicity, prolonged neutropenia, thrombocytopenia, secondary infections, fatigue.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is the primary clinical indication of Ciltacabtagene Autoleucel?
It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received multiple prior lines of therapy.
What is the core mechanism of this CAR-T Ciltacabtagene Autoleucel Injection?
It uses genetically modified autologous T cells to target BCMA on malignant plasma cells and trigger targeted cytotoxicity to eliminate tumor cells.
What are the main contraindications for Ciltacabtagene Autoleucel Injection?
It is prohibited for patients with severe uncontrolled infection, active autoimmune diseases, severe hypersensitivity, and pregnant or breastfeeding women.
What are the most common severe side effects of Ciltacabtagene Autoleucel Injection?
The major adverse reactions include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and severe cytopenia.
CARVYKTI® | Ciltacabtagene Autoleucel Injection | Myeloma | DengYueRX
INN: Ciltacabtagene Autoleucel Injection
Indications: Relapsed or refractory multiple myeloma
Dosage Form: Injection
Strength: 30ml/bag
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
Related Products
