NCT03464916

Study to Evaluate the Safety and Efficacy of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma Patients

A Phase 1, Open-Label, Dose-Escalation, Pharmacokinetic, and Pharmacodynamic Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label Phase 1 single dose-escalation safety study of CAR2 Anti-CD38 A2 CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma, who meet all other eligibility criteria.

Detailed description

All subjects who received investigational CAR-T therapy will be included in the analyses and summaries of safety, efficacy, pharmacokinetic, and pharmacodynamic assessments.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	CAR2 Anti-CD38 A2 CAR-T Cells	Autologous IV infusion; dose-escalation

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-08-23
• Completion: 2022-02-28
• First posted: 2018-03-14
• Last updated: 2022-03-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study