A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma, Refractory
- Sponsor
- Gadeta B.V.
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •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
Outcomes
Primary Outcomes
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
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)
Secondary Outcomes
- TEG002 efficacy by looking at Duration of response(Until Year 2)
- TEG002 efficacy by looking at Objective response rate(Until Year 2)
- 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)
- TEG002 efficacy by looking at Time to progression(Until Year 2)
- TEG002 pharmacokinetics measured in blood in bone marrow over time(Until Year 2)
- TEG002 efficacy by looking at Overall survival(Until Year 2)
- TEG002 efficacy by looking at Time to response(Until Year 2)
- TEG002 pharmacodynamics as measured by IL6 level in serum over time(until Year 2)
- TEG002 efficacy by looking at Progression free survival(Until Year 2)
- TEG002 pharmacodynamics as measured by CRP level in serum over time(until Year 2)
- TEG002 pharmacodynamics as measured by ferritin level in serum over time(until Year 2)