CARTITUDE

CARTITUDE is a clinical development program focused on cilta-cel, a BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy, for the treatment of multiple myeloma. The program is led by Legend Biotech in collaboration with Janssen Pharmaceuticals and includes multiple trials designed to evaluate cilta-cel across different disease settings and lines of therapy.

Mechanism and approach

CARTA- such therapies use autologous T cells collected from the patient, genetically modified to express a CAR that targets BCMA on myeloma cells. After lymphodepleting chemotherapy, the engineered T cells are infused back into the patient with the aim of producing a sustained anti-myeloma response. The CARTITUDE program seeks to determine how cilta-cel performs in terms of depth and duration of response, durability, and safety across various patient populations.

Clinical trials

The CARTITUDE program encompasses studies such as CARTITUDE-1, CARTITUDE-2, and CARTITUDE-3, among others. CARTITUDE-1 is a pivotal trial that informed regulatory assessments of cilta-cel. CARTITUDE-2 explores cilta-cel in different lines of therapy and treatment contexts, while CARTITUDE-3 investigates cilta-cel in comparison to other treatment options in specific settings. Collectively, these trials evaluate efficacy, durability of response, and safety, including adverse events associated with CAR-T therapy.

Regulatory status and impact

The CARTITUDE program contributed to regulatory submissions for cilta-cel (brand names Carvykti in some markets) as a treatment option for adults with relapsed or refractory multiple myeloma, with approvals granted in multiple jurisdictions. The program exemplifies the rapid development and assessment of BCMA-targeted CAR-T therapies and their potential role in the treatment landscape for multiple myeloma.

Safety considerations

As with other CAR-T products, cilta-cel within the CARTITUDE program has shown risks of cytokine release syndrome, neurotoxic events, and cytopenias. Safety monitoring and management guidelines accompany trial protocols and corresponding approvals.

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