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

Sponsor
Gadeta B.V. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04688853
Collaborator
(none)
26
3
1
38.6
8.7
0.2

Study Details

Study Description

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
  • Biological: TEG002
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs) [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 [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 [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 [Until Year 2]

    Efficacy: Objective response rate

  3. TEG002 efficacy by looking at Overall survival [Until Year 2]

    Efficacy: Overall survival

  4. TEG002 efficacy by looking at Progression free survival [Until Year 2]

    Efficacy: Progression free survival

  5. TEG002 efficacy by looking at Duration of response [Until Year 2]

    Efficacy: Duration of response

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

    Efficacy: Time to response

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

    Efficacy: Time to progression

  8. TEG002 pharmacokinetics measured in blood in bone marrow over time [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 [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 [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 [until Year 2]

    Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
3 Dana Farber Cancer Institute Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Gadeta B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gadeta B.V.
ClinicalTrials.gov Identifier:
NCT04688853
Other Study ID Numbers:
  • TEG002_MM_US_01
First Posted:
Dec 30, 2020
Last Update Posted:
Jul 12, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gadeta B.V.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021