NCT05007418

Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma

A Phase 1b, Open-Label Study of the Safety and Efficacy of Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor (DAR)-T Cells in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b, open-label, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma.

Detailed description

This is a phase 1b, open-label, multicenter, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma. The study will determine the MTD and RP2D, assessing safety and preliminary efficacy using a conventional 3+3 study design with two design stages, an ascending dose stage followed by an expansion study. Patients will be enrolled sequentially within each cohort and between cohorts during the dose escalation portion of the study with the staggered intervals of at least 28 days. Only one patient will be allowed to receive study treatment at any time through the end of the staggering period before the next subject may begin study treatment.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	STI-1492	Anti-CD38 A2 KOKI DAR T cells

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2021-08-16
• Last updated: 2023-01-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study