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

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.

Inclusion Criteria:

• Signed informed consent
• Adult
• Relapsed or refractory Multiple Myeloma as defined by the IMWG
• Life expectancy ≥3 months
• ECOG performance status 0 or 1
• Adequate vital organ function
• Adequate bone marrow function
• Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline
• WCBP and men who can father children must be willing and able to use adequate contraception

Exclusion Criteria:

• Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
• Pregnant or lactating women
• Amyloidosis
• Uncontrolled infection(s)
• Active CNS disease
• Previous allogeneic-HSCT
• History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year.
• Subjects that received experimental or systemic therapy < 14 days before TEG002 infusion
• NYHA Class ≥ II
• Patients depending on dialysis
• Patients with a history of pulmonary embolism or deep vein thrombosis
• T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy