Description
Indication & Scope
PuLiDeKai® Puzolcabtagene Autoleucel Injection treats relapsed or refractory CD19-positive acute B lymphoblastic leukemia in patients who need salvage chemotherapy after first remission for 12 months.
- Mechanism: It is autologous humanized anti-CD19 CAR-T cell therapy. Patient T cells are collected, genetically modified ex vivo to express chimeric antigen receptor targeting CD19 antigen on B-leukemia cells. Modified CAR-T cells bind CD19, activate cytotoxic pathways and eliminate malignant B lymphocytes.
- Drug class: Autologous chimeric antigen receptor T-cell immunotherapy / Anti-CD19 CAR-T biological drug.
- Clinical use: Curative treatment for relapsed/refractory pediatric and adolescent B-cell acute lymphoblastic leukemia with CD19 expression, indicated for patients failed prior multi-line chemotherapy.
| Generic Name | Puzolcabtagene Autoleucel Injection |
| Brand Name | PuLiDeKai |
| Ingredient | Puzolcabtagene Autoleucel |
| Dosage Form | Injection |
| Package | 22ml/bag(Target dose is 3.80 × 10 ^ 5-1.02 × 10 ^ 6 live anti-CD19 CAR-T cells per kg body weight, and the total number of live anti-CD19 CAR-T cells infused into each patient does not exceed 1.02 × 10 ^ 8);
50ml/bag(Target dose is 3.80 × 10 ^ 5-1.02 × 10 ^ 6 live anti-CD19 CAR-T cells per kg body weight, and the total number of live anti-CD19 CAR-T cells infused into each patient does not exceed 1.02 × 10 ^ 8) |
| Conditions Treated | Relapsed or refractory CD19-positive acute B lymphoblastic leukemia |
| Taboos | Patients with severe hypersensitivity to any cell therapy excipients; active uncontrolled severe systemic infection; active graft-versus-host disease; patients with poor cardiac, pulmonary or hepatic function unable to tolerate lymphodepletion chemotherapy |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store cryopreserved cell bags at ultra-low temperature ≤ -150°C in liquid nitrogen vapor phase; avoid repeated freezing and thawing |
| Manufacturer | JingZhun Biotechnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250058; S20250059 |
| Approval Date | Nov 4, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Single fixed dose of autologous CAR-T cells manufactured from patient’s own leukapheresis product, standardized cell count per patient weight.
Time: Complete leukapheresis cell collection first; finish lymphodepletion chemotherapy 2–5 days before single infusion; infuse cell product within 30 minutes after thawing.
Instructions for use: Full workflow patient leukapheresis for T cell harvest ex vivo cell engineering and culture lymphodepletion chemotherapy pretreatment single one-time intravenous infusion admit patient to ward for minimum 7-day continuous monitoring after infusion
Interaction: No formal drug interaction trials. Avoid concurrent high-dose immunosuppressants before infusion, which will inhibit CAR-T cell expansion; antibiotics shall be adjusted to control infection without suppressing T cell activity.
Side effects:
1. Common adverse reactions: cytokine release syndrome (fever, hypotension, hypoxia), neutropenia, thrombocytopenia, anemia, fatigue, headache.
2. Severe risks: immune effector cell-associated neurotoxicity syndrome (ICANS), severe infection, prolonged myelosuppression, tumor lysis syndrome.
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 primary disease does Puzolcabtagene Autoleucel Injection treat?
It treats relapsed and refractory CD19-positive acute B lymphoblastic leukemia.
What drug category does Puzolcabtagene Autoleucel Injection belong to?
It is autologous anti-CD19 CAR-T cell immunotherapy, a personalized biological therapy.
What core pretreatment step is required before infusion of Puzolcabtagene Autoleucel Injection?
Patients need to receive lymphodepletion chemotherapy to clear endogenous lymphocytes.
What are the two most severe potential adverse events after using Puzolcabtagene Autoleucel Injection?
Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS).
PuLiDeKai® | Puzolcabtagene Autoleucel Injection | B-Cell Lymphoblastic Leukemia | DengYueRX
INN: Puzolcabtagene Autoleucel Injection
Indications: B-cell lymphoblastic leukemia
Dosage Form: Injection
Strength: 22ml/bag; 50ml/bag
