NCT05396885

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

Detailed description

This is a Phase II open-label study of anitocabtagene-autoleucel \* in patients with relapsed or refractory multiple myeloma (MM). The study will have the following sequential phases: screening, enrollment, pre-treatment with lymphodepleting chemotherapy, treatment with anitocabtagene-autoleucel , and follow-up. If necessary, bridging therapy is allowed to control growth of MM disease while anitocabtagene-autoleucel is being manufactured. Following a single infusion of anitocabtagene-autoleucel both safety and efficacy data will be assessed. Efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years, or upon patient relapse. The primary analysis will be conducted approximately 13 months after the final patient is dosed. This will allow approximately 12 months follow up from the time of the last observed response on study. Long-term safety data will be collected under a separate long-term follow up study for up to 15 years per health authority guidelines. \*Anitocabtagene-autoleucel drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ξ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of anitocabtagene-autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	anitocabtagene-autoleucel	Anitocabtagene-autoleucel-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain

Timeline

• Start date: 2022-07-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-05-31
• Last updated: 2026-02-11

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study