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