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

NCT ID: NCT04688853

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2024-07-30

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.

Conditions

Multiple Myeloma, Refractory; Multiple Myeloma in Relapse; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TEG002

Intervention Type: BIOLOGICAL

TEG002 cells are autologous T cells transduced with a specific γδTCR

Interventions

TEG002

TEG002 cells are autologous T cells transduced with a specific γδTCR

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gadeta B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

TEG002_MM_US_01

Identifier Type: -

Identifier Source: org_study_id