Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Conditions
Keywords
T cell therapy, Engineered T Cells, TEG, TEGs, TEG002
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.
Interventions
BIOLOGICALTEG002
TEG002 cells are autologous T cells transduced with a specific γδTCR
Sponsors
Gadeta B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| TEG002 efficacy by looking at Time to progression | Until Year 2 | Efficacy: Time to progression |
| TEG002 efficacy by looking at Objective response rate | Until Year 2 | Efficacy: Objective response rate |
Countries
United States
Outcome results
None listed