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

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. 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.

Full Title of Study: “A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2023

Interventions

  • Biological: TEG002
    • TEG002 cells are autologous T cells transduced with a specific γδTCR

Arms, Groups and Cohorts

  • Experimental: Single Arm, Open label
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
    • Time Frame: Until day 28 following infusion
    • For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
  • Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
    • Time Frame: Until year 2
    • For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade

Secondary Measures

  • Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
    • Time Frame: Assessment per subject production run, timeframe: prior to day 0 for each subject
    • Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
  • TEG002 efficacy by looking at Objective response rate
    • Time Frame: Until Year 2
    • Efficacy: Objective response rate
  • TEG002 efficacy by looking at Overall survival
    • Time Frame: Until Year 2
    • Efficacy: Overall survival
  • TEG002 efficacy by looking at Progression free survival
    • Time Frame: Until Year 2
    • Efficacy: Progression free survival
  • TEG002 efficacy by looking at Duration of response
    • Time Frame: Until Year 2
    • Efficacy: Duration of response
  • TEG002 efficacy by looking at Time to response
    • Time Frame: Until Year 2
    • Efficacy: Time to response
  • TEG002 efficacy by looking at Time to progression
    • Time Frame: Until Year 2
    • Efficacy: Time to progression
  • TEG002 pharmacokinetics measured in blood in bone marrow over time
    • Time Frame: Until Year 2
    • Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time
  • TEG002 pharmacodynamics as measured by IL6 level in serum over time
    • Time Frame: until Year 2
    • Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time
  • TEG002 pharmacodynamics as measured by CRP level in serum over time
    • Time Frame: until Year 2
    • Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
  • TEG002 pharmacodynamics as measured by ferritin level in serum over time
    • Time Frame: until Year 2
    • Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gadeta B.V.
  • Provider of Information About this Clinical Study
    • Sponsor

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