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

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Overview

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.

SparkCures ID 1121
Trial Phase Phase 1
Enrollment Information Not Available
Treatments
  • TEG002
Trial Sponsors
  • Gadeta B.V.
NCT Identifier

NCT04688853

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

View Centers
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