Active Ingredient: Ciltacabtagene autoleucel
Ciltacabtagene autoleucel is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
750,000 - 750,000 [CCID_50] per kg of body weight
From 750,000 To 750,000 [CCID_50] per kg of body weight once every day
Ciltacabtagene autoleucel is intended for autologous use.
Treatment consists of a single dose for infusion containing a dispersion of CAR-positive viable T cells in one infusion bag.
The target dose is 0.75 × 106 CAR-positive viable T cells/kg of body weight (not exceeding 1.0 × 108 CAR-positive viable T cells).
Patients 100 kg and below: 0.5 – 1.0 × 106 CAR-positive viable T cells/kg body weight.
Patients above 100 kg: 0.5 – 1.0 × 108 CAR-positive viable T cells (non-weight based).
Consider bridging therapy according to prescriber’s choice prior to infusion with ciltacabtagene autoleucel to reduce tumour burden or stabilise the disease.
Lymphodepleting regimen must be delayed if a patient has serious adverse reactions from preceding bridging therapies (including clinically significant active infection, cardiac toxicity, and pulmonary toxicity).
The availability of ciltacabtagene autoleucel should be confirmed prior to starting the lymphodepleting regimen. A lymphodepleting regimen of cyclophosphamide 300 mg/m² intravenous and fludarabine 30 mg/m² intravenous should be administered daily for 3 days. Ciltacabtagene autoleucel infusion should be administered 5 to 7 days after the start of the lymphodepleting regimen. If resolution of toxicities due to the lymphodepleting regimen to Grade 1 or lower takes more than 14 days, thereby resulting in delays to ciltacabtagene autoleucel dosing, the lymphodepleting regimen should be re-administered after a minimum of 21 days following the first dose of the first lymphodepleting regimen.
For dose modifications of cyclophosphamide and fludarabine, see corresponding Summaries of Product Characteristics of cyclophosphamide and fludarabine.
The following pre-infusion medications should be administered to all patients 30 to 60 minutes prior to ciltacabtagene autoleucel infusion:
The use of prophylactic systemic corticosteroids should be avoided as it may interfere with the activity of ciltacabtagene autoleucel.
Do NOT use a leukodepleting filter.
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