Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT04688853

Recruitment Status:

Active, not recruiting

Sponsor:

Gadeta B.V.

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Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT04688853

Recruitment Status:

Active, not recruiting

Sponsor:


Gadeta B.V.

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