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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04688853
Other study ID # TEG002_MM_US_01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date May 13, 2021
Est. completion date July 30, 2024

Study information

Verified date September 2022
Source Gadeta B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
TEG002
TEG002 cells are autologous T cells transduced with a specific ?dTCR

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gadeta B.V.

Country where clinical trial is conducted

United States, 

Outcome

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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