NCT04688853

A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients

A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Gadeta B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients. The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.

Conditions

• Multiple Myeloma, Refractory
• Multiple Myeloma in Relapse
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	TEG002	TEG002 cells are autologous T cells transduced with a specific γδTCR

Timeline

• Start date: 2021-05-13
• Primary completion: 2023-07-30
• Completion: 2024-07-30
• First posted: 2020-12-30
• Last updated: 2022-09-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study