Recommended Dose: 0.5×10⁸ viable CAR-T cells, with a range of 0.25×10⁸–0.5×10⁸ viable CAR-T cells (±20%, i.e., 0.2×10⁸–0.6×10⁸ viable CAR-T cells). The infusion volume is determined based on the number of viable CAR-T cells and the recommended dose.

Time:

1. Lymphodepleting chemotherapy is usually administered 2–5 days before infusion.

2. The infusion is given as a single administration, typically completed within 30–60 minutes.

3. Post-infusion monitoring is required for at least 14 days in a qualified medical center.

Instructions for use:

1. This is an autologous cell therapy product, prepared from the patient’s own T cells.

2. Lymphodepleting chemotherapy (e.g., cyclophosphamide + fludarabine) must be completed before infusion to optimize efficacy.

3. Thaw the product immediately before use in a sterile environment; do not refreeze after thawing.

4. Administer as a slow intravenous infusion, and monitor the patient closely during and after infusion.

5. Manage adverse events (e.g., CRS, ICANS) per institutional guidelines; tocilizumab and supportive care should be readily available.

Interaction:

1. No formal drug interaction studies have been conducted with this CAR-T product.

2. Avoid live vaccines before and after treatment, as the patient’s immune function is impaired.

3. Concurrent use of immunosuppressants (except those used for lymphodepletion) may reduce the expansion and efficacy of CAR-T cells.

4. Use caution with drugs that affect platelet function or coagulation, as thrombocytopenia is a common post-infusion adverse event.

Side effects: Immune effect cell-related neurotoxic syndrome, decreased platelet count, anemia, decreased neutrophil count, infectious pneumonia, anal abscess, cobacterial disease, pseudomonas sepsis, soft tissue infection, bone marrow suppression, decreased white blood cell count.