TEG002 for Refractory Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Refractory Multiple Myeloma+2 MoreTEG002 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for multiple myeloma that uses the patient's own T cells that have been modified to express a γδTCR. The study will assess the safety and efficacy of this treatment in a small group of patients.

Eligible Conditions
  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma Relapse

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: until Year 2

Day 0
Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
Until Year 2
TEG002 efficacy by looking at Duration of response
TEG002 efficacy by looking at Objective response rate
TEG002 efficacy by looking at Overall survival
TEG002 efficacy by looking at Progression free survival
TEG002 efficacy by looking at Time to progression
TEG002 efficacy by looking at Time to response
TEG002 pharmacokinetics measured in blood in bone marrow over time
Day 28
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
Until year 2
Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
until Year 2
TEG002 pharmacodynamics as measured by CRP level in serum over time
TEG002 pharmacodynamics as measured by IL6 level in serum over time
TEG002 pharmacodynamics as measured by ferritin level in serum over time

Trial Safety

Trial Design

1 Treatment Group

Single Arm, Open label
1 of 1

Experimental Treatment

26 Total Participants · 1 Treatment Group

Primary Treatment: TEG002 · No Placebo Group · Phase 1

Single Arm, Open label
Biological
Experimental Group · 1 Intervention: TEG002 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until year 2

Who is running the clinical trial?

Gadeta B.V.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have received no prior/ongoing therapy.
You are willing and able to use adequate contraception.