A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
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 |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- 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)
- 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
- 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
- TEG002 efficacy by looking at Objective response rate [Until Year 2]
Efficacy: Objective response rate
- TEG002 efficacy by looking at Overall survival [Until Year 2]
Efficacy: Overall survival
- TEG002 efficacy by looking at Progression free survival [Until Year 2]
Efficacy: Progression free survival
- TEG002 efficacy by looking at Duration of response [Until Year 2]
Efficacy: Duration of response
- TEG002 efficacy by looking at Time to response [Until Year 2]
Efficacy: Time to response
- TEG002 efficacy by looking at Time to progression [Until Year 2]
Efficacy: Time to progression
- 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
- 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
- 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
- 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
Inclusion Criteria:
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Signed informed consent
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Adult
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Relapsed or refractory Multiple Myeloma as defined by the IMWG
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Life expectancy ≥3 months
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ECOG performance status 0 or 1
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Adequate vital organ function
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Adequate bone marrow function
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Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline
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WCBP and men who can father children must be willing and able to use adequate contraception
Exclusion Criteria:
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Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
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Pregnant or lactating women
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Amyloidosis
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Uncontrolled infection(s)
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Active CNS disease
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Previous allogeneic-HSCT
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History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year.
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Subjects that received experimental or systemic therapy < 14 days before TEG002 infusion
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NYHA Class ≥ II
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Patients depending on dialysis
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Patients with a history of pulmonary embolism or deep vein thrombosis
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T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- TEG002_MM_US_01