Carvykti

Multiple myeloma — relapsed or refractory, after four or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Lymphodepleting chemotherapy: Cyclophosphamide 300 mg/m² IV + fludarabine 30 mg/m² IV daily for 3 days, completed 5-7 days before infusion
Carvykti infusion: 0.5-1.0 × 10⁶ CAR-positive viable T cells/kg as single IV infusion
Pre-medication: Acetaminophen and diphenhydramine 30-60 min before
Monitor in REMS-certified healthcare facility

Cell suspension for IV infusion; patient-specific infusion bag containing 0.5-1.0 × 10⁶ CAR-positive viable T cells per kg body weight (range 0.5-1.0 × 10⁸ total cells)

None listed.

• CRS: 95% (5% Grade ≥3). Median onset: 7 days (range 1-12). Median duration: 4 days. Manage with tocilizumab ± corticosteroids.
• ICANS: 23% (3% Grade ≥3). Median onset: 8 days.
• Movement and Neurocognitive Adverse Events: Parkinsonism (4%), cranial nerve palsies, peripheral neuropathy, Guillain-Barré syndrome. Can be late-onset (weeks to months). Some cases fatal.
• HLH/MAS: 1% (potentially fatal).
• Prolonged Cytopenias: Grade 3-4 not resolved by Day 30: thrombocytopenia (41%), neutropenia (41%), anemia (12%).
• Infections: 57% (20% Grade ≥3). Screen for and treat active infections before infusion.
• Hypogammaglobulinemia: 12%.
• Secondary Malignancies: Including T-cell malignancies.

CRS (95%), pyrexia (95%), neutropenia (95%), thrombocytopenia (80%), anemia (68%), musculoskeletal pain (57%), fatigue (42%), infections (57%), GI disorders (48%), encephalopathy (21%), lymphopenia (19%)

CRS in 95% (Grade 3+ in 4%). Neurotoxicity in 21% (ICANS 17%, other including parkinsonism/GBS 8%). HLH/MAS reported.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 95% (Grade 3+ in 4%). Neurotoxicity in 21% (ICANS 17%, other including parkinsonism/GBS 8%). HLH/MAS reported.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Ciltacabtagene autoleucel is a BCMA-directed genetically modified autologous T-cell immunotherapy. Patient T cells are transduced with a lentiviral vector encoding a CAR containing two BCMA-targeting single-domain antibodies (VHH) designed to confer high-avidity binding, linked to a 4-1BB costimulatory domain and CD3-zeta signaling domain. The dual-binding VHH design differentiates it from other BCMA CAR T therapies by providing enhanced BCMA engagement.

Peak CAR T-cell expansion: median 10-14 days. T cells detectable in blood for 6+ months. Higher Cmax associated with greater depth of response. Primarily distributed in peripheral blood and bone marrow.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• CARTITUDE-1 — Ciltacabtagene autoleucel in heavily pretreated relapsed/refractory MM. Phase Ib/II, n=97.
  🔬 NCT03548207 ↗ 📄 Primary Publication ↗

Carvykti has FDA-approved indications across the following cancer types covered on PipelineEvidence: