Ciltacabtagene Autoleucel
Ciltacabtagene Autoleucel is a personalized CAR-T cell therapy that reprograms a patient's own T cells to recognize and attack cancer cells expressing B-cell maturation antigen (BCMA). This one-time treatment is designed for patients with relapsed or refractory multiple myeloma who have received prior therapies. The modified cells are then infused back into the patient to target and eliminate myeloma cells.
A BCMA-directed CAR-T cell therapy for relapsed or refractory multiple myeloma that uses the patient's own modified immune cells to target and destroy cancer.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XL05
- RxNorm
- 2594775
- Generic
- Ciltacabtagene Autoleucel
- Class
- atc-l01
- Brands
- Carvykti
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 0.5-1.0 x 10^6 CAR-positive T cells per kg (max dose: 1 x 10^8 CAR-positive T cells)
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established - refer to protocol
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5-1.0 x 10^6 CAR-positive T cells per kg (max dose: 1 x 10^8 CAR-positive T cells)
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
generalavoid if possible
avoid use during pregnancy unless benefits outweigh risks; discuss potential fetal harm with patient
regular fetal monitoring if used
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
generalavoid
discontinue breastfeeding during treatment and for at least 12 months after administration
none established
pediatric_age
children adolescentsnot applicable
not approved for pediatric patients; safety and efficacy not established in patients under 18 years
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 yearsno specific adjustment required
use with caution; increased vigilance for cytokine release syndrome and neurotoxicity recommended
close monitoring for adverse reactions including CRS and ICANS
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno dose adjustment required
can be administered to patients with mild to moderate renal impairment; monitor renal function
monitor renal function before and after treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno dose adjustment required
can be administered to patients with mild to moderate hepatic impairment; monitor hepatic function
monitor hepatic function before and after treatment
Use with caution and monitor for adverse effects.
alcohol_users
chronic heavy useno specific adjustment
use with caution; alcohol may exacerbate liver dysfunction and increase infection risk
monitor liver function and for increased susceptibility to infections
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval date for Carvykti
Drug class
BCMA-directed autologous cellular immunotherapy
Indication
Approved indication for adult patients
Target
Mechanism of action
Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Ciltacabtagene Autoleucel is an autologous cell therapy where patient T cells are collected, genetically engineered to express a chimeric antigen receptor (CAR) targeting BCMA on the cell surface, expanded in number, and infused back to the patient. The CAR binds to BCMA on myeloma cells, triggering T cell activation and subsequent cancer cell destruction.
Administered as a single intravenous infusion following lymphodepleting chemotherapy. Associated with serious risks including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), prolonged cytopenias, infections, and hypogammaglobulinemia. Requires close monitoring with facilities trained to manage these complications. REMS (Risk Evaluation and Mitigation Strategy) program enrollment required.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy