Status:
UNKNOWN
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
Lead Sponsor:
Gadeta B.V.
Conditions:
Multiple Myeloma, Refractory
Multiple Myeloma in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04688853
Start Date
May 13 2021
End Date
July 30 2024
Last Update
September 8 2022
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215