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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04688853
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Gadeta B.V.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma, Refractory Multiple Myeloma in Relapse Multiple Myeloma Biological: TEG002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. 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

  2. TEG002 efficacy by looking at Objective response rate [ Time Frame: Until Year 2 ]
    Efficacy: Objective response rate

  3. TEG002 efficacy by looking at Overall survival [ Time Frame: Until Year 2 ]
    Efficacy: Overall survival

  4. TEG002 efficacy by looking at Progression free survival [ Time Frame: Until Year 2 ]
    Efficacy: Progression free survival

  5. TEG002 efficacy by looking at Duration of response [ Time Frame: Until Year 2 ]
    Efficacy: Duration of response

  6. TEG002 efficacy by looking at Time to response [ Time Frame: Until Year 2 ]
    Efficacy: Time to response

  7. TEG002 efficacy by looking at Time to progression [ Time Frame: Until Year 2 ]
    Efficacy: Time to progression

  8. 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

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688853


Contacts
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Contact: Kirsty van Nierop +31850164445 k.vannierop@gadeta.nl

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Betsy Valles    617-643-9072    bvalles@mgh.harvard.edu   
Principal Investigator: Andrew Branagan, MD, PhD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Emma Logan    617-667-5984    EKLogan@BIDMC.harvard.edu   
Principal Investigator: David Avigan, MD, PhD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Denbaa Bat-Erdene    617-582-9565    Denbaa_Bat-Erdene@dfci.harvard.edu   
Principal Investigator: Adam Sperling, MD PhD         
Sponsors and Collaborators
Gadeta B.V.
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Responsible Party: Gadeta B.V.
ClinicalTrials.gov Identifier: NCT04688853    
Other Study ID Numbers: TEG002_MM_US_01
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gadeta B.V.:
T cell therapy
Engineered T Cells
TEG
TEGs
TEG002
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases