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

Phase 1

Active, not recruiting

• Conditions: Multiple Myeloma, Refractory; Multiple Myeloma in Relapse; Multiple Myeloma
• Interventions: Biological: TEG002

• Registration Number: NCT04688853
• Lead Sponsor: Gadeta B.V.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Study Start: 2021-05-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-08
• Primary Completion: 2023-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm, Open label	TEG002	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

Primary Outcome Measures

Name	Time	Method
Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade	Until year 2	For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)	Until day 28 following infusion	For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
TEG002 efficacy by looking at Objective response rate	Until Year 2	Efficacy: Objective response rate
TEG002 efficacy by looking at Duration of response	Until Year 2	Efficacy: Duration of response
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	Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
TEG002 efficacy by looking at Time to progression	Until Year 2	Efficacy: Time to progression
TEG002 pharmacokinetics measured in blood in bone marrow over time	Until Year 2	Safety \& Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time
TEG002 efficacy by looking at Overall survival	Until Year 2	Efficacy: Overall survival
TEG002 efficacy by looking at Time to response	Until Year 2	Efficacy: Time to response
TEG002 pharmacodynamics as measured by IL6 level in serum over time	until Year 2	Safety \& Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time
TEG002 efficacy by looking at Progression free survival	Until Year 2	Efficacy: Progression free survival
TEG002 pharmacodynamics as measured by CRP level in serum over time	until Year 2	Safety \& Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
TEG002 pharmacodynamics as measured by ferritin level in serum over time	until Year 2	Safety \& Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States