Back to resultsA Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
Primary Purpose
Multiple Myeloma, Refractory, Multiple Myeloma in Relapse, Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TEG002
Sponsored by
About this trial
This is an interventional other trial for Multiple Myeloma, Refractory focused on measuring T cell therapy, Engineered T Cells, TEG, TEGs, 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
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm, Open label
Arm Description
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
Outcomes
Primary Outcome Measures
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
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
For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Secondary Outcome 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
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
Efficacy: Objective response rate
TEG002 efficacy by looking at Overall survival
Efficacy: Overall survival
TEG002 efficacy by looking at Progression free survival
Efficacy: Progression free survival
TEG002 efficacy by looking at Duration of response
Efficacy: Duration of response
TEG002 efficacy by looking at Time to response
Efficacy: Time to response
TEG002 efficacy by looking at Time to progression
Efficacy: Time to progression
TEG002 pharmacokinetics measured in blood in bone marrow over time
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
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
Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
TEG002 pharmacodynamics as measured by ferritin level in serum over time
Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04688853
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gadeta B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Refractory, Multiple Myeloma in Relapse, Multiple Myeloma
Keywords
T cell therapy, Engineered T Cells, TEG, TEGs, TEG002
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm, Open label
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
TEG002
Intervention Description
TEG002 cells are autologous T cells transduced with a specific γδTCR
Primary Outcome Measure Information:
Title
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
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)
Time Frame
Until day 28 following infusion
Title
Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Description
For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Time Frame
Until year 2
Secondary Outcome Measure Information:
Title
Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
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
Time Frame
Assessment per subject production run, timeframe: prior to day 0 for each subject
Title
TEG002 efficacy by looking at Objective response rate
Description
Efficacy: Objective response rate
Time Frame
Until Year 2
Title
TEG002 efficacy by looking at Overall survival
Description
Efficacy: Overall survival
Time Frame
Until Year 2
Title
TEG002 efficacy by looking at Progression free survival
Description
Efficacy: Progression free survival
Time Frame
Until Year 2
Title
TEG002 efficacy by looking at Duration of response
Description
Efficacy: Duration of response
Time Frame
Until Year 2
Title
TEG002 efficacy by looking at Time to response
Description
Efficacy: Time to response
Time Frame
Until Year 2
Title
TEG002 efficacy by looking at Time to progression
Description
Efficacy: Time to progression
Time Frame
Until Year 2
Title
TEG002 pharmacokinetics measured in blood in bone marrow over time
Description
Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time
Time Frame
Until Year 2
Title
TEG002 pharmacodynamics as measured by IL6 level in serum over time
Description
Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time
Time Frame
until Year 2
Title
TEG002 pharmacodynamics as measured by CRP level in serum over time
Description
Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
Time Frame
until Year 2
Title
TEG002 pharmacodynamics as measured by ferritin level in serum over time
Description
Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time
Time Frame
until Year 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
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