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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What's being studied?

  • TEG002

Additional Trial Information

Phase 1

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

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
View Additional Criteria

Trial Locations

All Trial Locations

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Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Not Yet Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting
Interested in this trial?
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