Multiple Myeloma Clinical Trial
Official title:
A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Verified date | September 2022 |
Source | Gadeta B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 26 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Gadeta B.V. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Until day 28 following infusion | |
Primary | 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 | Until year 2 | |
Secondary | 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 | Assessment per subject production run, timeframe: prior to day 0 for each subject | |
Secondary | TEG002 efficacy by looking at Objective response rate | Efficacy: Objective response rate | Until Year 2 | |
Secondary | TEG002 efficacy by looking at Overall survival | Efficacy: Overall survival | Until Year 2 | |
Secondary | TEG002 efficacy by looking at Progression free survival | Efficacy: Progression free survival | Until Year 2 | |
Secondary | TEG002 efficacy by looking at Duration of response | Efficacy: Duration of response | Until Year 2 | |
Secondary | TEG002 efficacy by looking at Time to response | Efficacy: Time to response | Until Year 2 | |
Secondary | TEG002 efficacy by looking at Time to progression | Efficacy: Time to progression | Until Year 2 | |
Secondary | TEG002 pharmacokinetics measured in blood in bone marrow over time | Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time | Until Year 2 | |
Secondary | 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 | until Year 2 | |
Secondary | TEG002 pharmacodynamics as measured by CRP level in serum over time | Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time | until Year 2 | |
Secondary | TEG002 pharmacodynamics as measured by ferritin level in serum over time | Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time | until Year 2 |
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