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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
• Intervention / Treatment: Biological: TEG002

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm, Open label; 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

Biological: TEG002; TEG002 cells are autologous T cells transduced with a specific γδTCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
TEG002 efficacy by looking at Objective response rate	Efficacy: Objective response rate	Until Year 2
TEG002 efficacy by looking at Overall survival	Efficacy: Overall survival	Until Year 2
TEG002 efficacy by looking at Progression free survival	Efficacy: Progression free survival	Until Year 2
TEG002 efficacy by looking at Duration of response	Efficacy: Duration of response	Until Year 2
TEG002 efficacy by looking at Time to response	Efficacy: Time to response	Until Year 2
TEG002 efficacy by looking at Time to progression	Efficacy: Time to progression	Until Year 2
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
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
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
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

Collaborators and Investigators

• Sponsor: Gadeta B.V.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: TEG; T cell therapy; Engineered T Cells; TEGs; TEG002
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: TEG002_MM_US_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No