Clinical Trials /

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

NCT04688853

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: TEG002_MM_US_01
  • NCT ID: NCT04688853

Conditions

  • Multiple Myeloma, Refractory
  • Multiple Myeloma in Relapse
  • Multiple Myeloma

Interventions

DrugSynonymsArms
TEG002Single Arm, Open label

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Single Arm, Open labelExperimentalThis 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
  • TEG002

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Measure: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 D0 for each subject
Safety Issue:
Description:Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
Measure:TEG002 efficacy by looking at Objective response rate
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Objective response rate
Measure:TEG002 efficacy by looking at Overall survival
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Overall survival
Measure:TEG002 efficacy by looking at Progression free survival
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Progression free survival
Measure:TEG002 efficacy by looking at Duration of response
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Duration of response
Measure:TEG002 efficacy by looking at Time to response
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Time to response
Measure:TEG002 efficacy by looking at Time to progression
Time Frame:Until Year 2
Safety Issue:
Description:Efficacy: Time to progression
Measure:TEG002 pharmacokinetics measured in blood in bone marrow over time
Time Frame:Until Year 2
Safety Issue:
Description:Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time
Measure:TEG002 pharmacodynamics as measured by IL6 level in serum over time
Time Frame:until Year 2
Safety Issue:
Description:Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time
Measure:TEG002 pharmacodynamics as measured by CRP level in serum over time
Time Frame:until Year 2
Safety Issue:
Description:Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
Measure:TEG002 pharmacodynamics as measured by ferritin level in serum over time
Time Frame:until Year 2
Safety Issue:
Description:Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Gadeta B.V.

Trial Keywords

  • T cell therapy
  • Engineered T Cells
  • TEG
  • TEGs
  • TEG002

Last Updated

December 30, 2020