Clinical trial NCT04688853: A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
Official title: A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Myeloma, Refractory
Multiple Myeloma in Relapse
Multiple Myeloma
Keywords: T cell therapy
Engineered T Cells
TEG
TEGs
TEG002
Lead sponsor: Gadeta B.V.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
timeFrame: Until day 28 following infusion
measure: Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
timeFrame: Until year 2
Secondary outcomes:
measure: Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
timeFrame: Assessment per subject production run, timeframe: prior to day 0 for each subject
measure: TEG002 efficacy by looking at Objective response rate
timeFrame: Until Year 2
measure: TEG002 efficacy by looking at Overall survival
timeFrame: Until Year 2
measure: TEG002 efficacy by looking at Progression free survival
timeFrame: Until Year 2
measure: TEG002 efficacy by looking at Duration of response
timeFrame: Until Year 2
measure: TEG002 efficacy by looking at Time to response
timeFrame: Until Year 2
measure: TEG002 efficacy by looking at Time to progression
timeFrame: Until Year 2
measure: TEG002 pharmacokinetics measured in blood in bone marrow over time
timeFrame: Until Year 2
measure: TEG002 pharmacodynamics as measured by IL6 level in serum over time
timeFrame: until Year 2
measure: TEG002 pharmacodynamics as measured by CRP level in serum over time
timeFrame: until Year 2
measure: TEG002 pharmacodynamics as measured by ferritin level in serum over time
timeFrame: until Year 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
References: