Description
Indication & Scope
PuLiDeKai® is a prescription autologous CD19 CAR-T cell therapy indicated for the treatment of pediatric and adolescent patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
- Mechanism: Puzolcabtagene autoleucel is an autologous T-cell therapy genetically modified to express a CD19-specific chimeric antigen receptor (CAR). The CAR structure contains a humanized FMC63-derived scFv and 4-1BB/CD3ζ signaling domains, enabling recognition of CD19-expressing malignant B cells and activation of T-cell-mediated cytotoxicity.
- Drug class: Autologous CD19-directed CAR-T cell therapy.
- Clinical use: Treatment of pediatric and adolescent patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
| Generic Name | Puzolcabtagene Autoleucel Injection |
| Brand Name | PuLiDeKai® |
| Ingredient | Autologous anti-CD19 CAR-T cells |
| Dosage Form | Injection |
| Package | 22 mL/bag; 50 mL/bag |
| Conditions Treated | R/R CD19-positive B-cell acute lymphoblastic leukemia |
| Taboos | Hypersensitivity to any component of the product; active severe infection; severe organ dysfunction; pregnancy |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Cryopreserved in liquid nitrogen vapor phase (≤ -150°C) |
| Manufacturer | Chongqing Precision Biotech Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250058; S20250059 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended dose is 3.80 × 10⁵ to 1.02 × 10⁶ viable anti-CD19 CAR-T cells/kg body weight, administered as a single intravenous infusion. The maximum dose should not exceed 1.02 × 10⁸ viable anti-CD19 CAR-T cells per patient.
Time: Administer as a single intravenous infusion following completion of lymphodepleting chemotherapy. The infusion duration should follow the approved prescribing information.
Instructions for use: Puzolcabtagene autoleucel is an autologous CD19-directed CAR-T cell therapy prepared individually for each patient. Administer only in qualified treatment centers after lymphodepleting chemotherapy. Patients should be closely monitored for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, and other treatment-related adverse events for at least 28 days after infusion.
Interaction: No formal drug interaction studies have been conducted. As a cellular immunotherapy, Puzolcabtagene autoleucel is not metabolized by CYP450 enzymes. Concomitant use of immunosuppressive agents should generally be avoided except when clinically indicated for the management of CAR-T-related toxicities.
Side effects: Common adverse reactions include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), pyrexia, cytopenia, infections, fatigue, hypotension, hypogammaglobulinemia, nausea, and headache.
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 PuLiDeKai® used for?
PuLiDeKai® is used for pediatric and adolescent patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
What type of therapy is Puzolcabtagene autoleucel?
It is an autologous CD19-directed CAR-T cell therapy.
How does Puzolcabtagene autoleucel work?
It modifies the patient’s own T cells to recognize and eliminate CD19-expressing leukemia cells.
How is the drug administered?
It is administered as a one-time intravenous infusion after preparation of patient-derived CAR-T cells.
PuLiDeKai® | Puzolcabtagene Autoleucel | R/R B-cell Acute Lymphoblastic Leukemia | DengYueRX
INN: Puzolcabtagene autoleucel
Indications: R/R CD19-positive B-cell acute lymphoblastic leukemia
Dosage Form: Injection (CAR-T cell suspension)
Strength: 22 mL/bag; 50 mL/bag
