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

Gadeta

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma; Multiple Myeloma, Refractory

Treatments: Biological: TEG002

Study type: Interventional

Funder types: Industry

Identifiers

NCT04688853

TEG002_MM_US_01

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Single Arm, Open label

Experimental group

Description:

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

Treatment:

Biological: TEG002