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
  • Phase

    Phase 1
  • Study Type

  • Status

    Active, not recruiting
  • Intervention/Treatment

  • Study Participants

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.
Study Started
May 13
Primary Completion
Jul 30
Study Completion
Jul 30
Last Update
Sep 08

Biological TEG002

TEG002 cells are autologous T cells transduced with a specific γδTCR

Single Arm, Open label Experimental

This is a single arm, open-label, multicenter phase I study with a dose escalation and an expansion segment. For the Dose escalation segment, 3-9 patients per dose cohort will receive: Dose level 1: Low Dose level 2: Medium Dose level 3: High For the expansion segment, additional patients may be enrolled until a maximum of 20 patients have received the recommended dose


Inclusion Criteria:

Signed informed consent
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
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
No Results Posted