Beinuoda Relmacabtagene Autoleucel Injection

1. Indications and Usage
Relapsed or Refractory Large B-Cell Lymphoma (LBCL):
Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma arising from follicular lymphoma.
Relapsed or Refractory Follicular Lymphoma (FL):
Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY.
Recommended Dosage:
Dose: The recommended dose is 100 × 10⁶ CAR-T cells.
Preparation: The infusion volume is calculated based on the product Information Sheet.
Administration Instructions:
Thawing: Thaw at room temperature; do not heat.
Infusion: Administer slowly via intravenous infusion.
Pre-medication: Lymphodepleting chemotherapy (e.g., cyclophosphamide and fludarabine) is required prior to infusion.
3. Mechanism of Action
CAR-T Technology:
Relmacabtagene autoleucel is an autologous T-cell suspension expressing a chimeric antigen receptor (CAR) that targets CD19.
Tumor Elimination:
The CAR consists of an extracellular CD19-binding domain and an intracellular signaling domain. Upon binding to CD19-positive tumor cells, it activates the T cells to kill the target cells.
4. Safety and Warnings
Cytokine Release Syndrome (CRS):
May cause severe or fatal CRS. Monitor patients for signs of CRS (fever, hypotension). Treat severe CRS with tocilizumab and/or corticosteroids.
Neurological Toxicity (NT):
May cause severe or fatal neurological toxicity (e.g., encephalopathy).
Infections:
May cause severe and fatal infections. Do not administer to patients with active infection.
Prolonged Cytopenias:
Monitor complete blood counts regularly.
5. Adverse Reactions
Most Common:
Neutropenia, pyrexia, leukopenia, CRS, hypogammaglobulinemia, thrombocytopenia, lymphopenia, and NT.
6. Drug Interactions
Immunosuppressants:
Systemic corticosteroids and other immunosuppressive drugs may interfere with the efficacy of Relmacabtagene Autoleucel. Avoid use prior to infusion unless required for managing CRS or NT.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Relmacabtagene Autoleucel (Autologous T cells expressing CD19 CAR).
Storage:
Store in a freezer at or below -180°C in vapor phase of liquid nitrogen.