A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04688853
• Other study ID #: TEG002_MM_US_01
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory
• Neoplasms, Plasma Cell

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