Description:
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.
Title
- Brief Title: A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
- Official Title: A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
Clinical Trial IDs
- ORG STUDY ID:
TEG002_MM_US_01
- NCT ID:
NCT04688853
Conditions
- Multiple Myeloma, Refractory
- Multiple Myeloma in Relapse
- Multiple Myeloma
Interventions
Drug | Synonyms | Arms |
---|
TEG002 | | Single Arm, Open label |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Single Arm, Open label | Experimental | 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 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs) |
Time Frame: | Until day 28 following infusion |
Safety Issue: | |
Description: | For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients |
Time Frame: | Assessment per subject production run, timeframe: prior to day 0 for each subject |
Safety Issue: | |
Description: | Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients |
Measure: | TEG002 efficacy by looking at Objective response rate |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Objective response rate |
Measure: | TEG002 efficacy by looking at Overall survival |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Overall survival |
Measure: | TEG002 efficacy by looking at Progression free survival |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Progression free survival |
Measure: | TEG002 efficacy by looking at Duration of response |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Duration of response |
Measure: | TEG002 efficacy by looking at Time to response |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Time to response |
Measure: | TEG002 efficacy by looking at Time to progression |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Efficacy: Time to progression |
Measure: | TEG002 pharmacokinetics measured in blood in bone marrow over time |
Time Frame: | Until Year 2 |
Safety Issue: | |
Description: | Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time |
Measure: | TEG002 pharmacodynamics as measured by IL6 level in serum over time |
Time Frame: | until Year 2 |
Safety Issue: | |
Description: | Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time |
Measure: | TEG002 pharmacodynamics as measured by CRP level in serum over time |
Time Frame: | until Year 2 |
Safety Issue: | |
Description: | Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time |
Measure: | TEG002 pharmacodynamics as measured by ferritin level in serum over time |
Time Frame: | until Year 2 |
Safety Issue: | |
Description: | Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Gadeta B.V. |
Trial Keywords
- T cell therapy
- Engineered T Cells
- TEG
- TEGs
- TEG002
Last Updated
July 12, 2021