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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
For the expansion segment, additional patients may be enrolled until a maximum of 20 patients have received the recommended dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG002 | Biological | TEG002 cells are autologous T cells transduced with a specific γδTCR |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| 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 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |