Title
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Phase
Phase 1Lead Sponsor
Gadeta B.V.Study Type
InterventionalStatus
Active, not recruitingIndication/Condition
Multiple Myeloma, Refractory Multiple Myeloma in Relapse ...Intervention/Treatment
TEG002Study Participants
26This 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.
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
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
