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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients

Conditions
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Multiple Myeloma, Refractory, Multiple Myeloma in Relapse, Multiple Myeloma

Intervention / Treatment
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* Biological: TEG002


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm, Open label<br>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 | Biological: TEG002<br>* TEG002 cells are autologous T cells transduced with a specific γδTCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs) | For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs) | Until day 28 following infusion | 
| Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade | For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade | Until year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients | Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients | Assessment per subject production run, timeframe: prior to day 0 for each subject | 
| TEG002 efficacy by looking at Objective response rate | Efficacy: Objective response rate | Until Year 2 | 
| TEG002 efficacy by looking at Overall survival | Efficacy: Overall survival | Until Year 2 | 
| TEG002 efficacy by looking at Progression free survival | Efficacy: Progression free survival | Until Year 2 | 
| TEG002 efficacy by looking at Duration of response | Efficacy: Duration of response | Until Year 2 | 
| TEG002 efficacy by looking at Time to response | Efficacy: Time to response | Until Year 2 | 
| TEG002 efficacy by looking at Time to progression | Efficacy: Time to progression | Until Year 2 | 
| TEG002 pharmacokinetics measured in blood in bone marrow over time | Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time | Until Year 2 | 
| TEG002 pharmacodynamics as measured by IL6 level in serum over time | Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time | until Year 2 | 
| TEG002 pharmacodynamics as measured by CRP level in serum over time | Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time | until Year 2 | 
| TEG002 pharmacodynamics as measured by ferritin level in serum over time | Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time | until Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEG, T cell therapy, Engineered T Cells, TEGs, TEG002