A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
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ClinicalTrials.gov Identifier: NCT04688853 |
Recruitment Status :
Active, not recruiting
First Posted : December 30, 2020
Last Update Posted : September 8, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma, Refractory Multiple Myeloma in Relapse Multiple Myeloma | Biological: TEG002 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients |
Actual Study Start Date : | May 13, 2021 |
Estimated Primary Completion Date : | July 30, 2023 |
Estimated Study Completion Date : | July 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Single Arm, Open label
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 |
Biological: TEG002
TEG002 cells are autologous T cells transduced with a specific γδTCR |
- 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 ]For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
- Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade [ Time Frame: Until year 2 ]For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
- 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 ]Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients
- TEG002 efficacy by looking at Objective response rate [ Time Frame: Until Year 2 ]Efficacy: Objective response rate
- TEG002 efficacy by looking at Overall survival [ Time Frame: Until Year 2 ]Efficacy: Overall survival
- TEG002 efficacy by looking at Progression free survival [ Time Frame: Until Year 2 ]Efficacy: Progression free survival
- TEG002 efficacy by looking at Duration of response [ Time Frame: Until Year 2 ]Efficacy: Duration of response
- TEG002 efficacy by looking at Time to response [ Time Frame: Until Year 2 ]Efficacy: Time to response
- TEG002 efficacy by looking at Time to progression [ Time Frame: Until Year 2 ]Efficacy: Time to progression
- TEG002 pharmacokinetics measured in blood in bone marrow over time [ Time Frame: Until Year 2 ]Safety & Efficacy: TEG002 persistence measured by qPCR in blood in bone marrow over time
- TEG002 pharmacodynamics as measured by IL6 level in serum over time [ Time Frame: until Year 2 ]Safety & Efficacy: TEG002 pharmacodynamics measured by the level of IL6 in serum over time
- TEG002 pharmacodynamics as measured by CRP level in serum over time [ Time Frame: until Year 2 ]Safety & Efficacy: TEG002 pharmacodynamics measured by the CRP level in serum over time
- TEG002 pharmacodynamics as measured by ferritin level in serum over time [ Time Frame: until Year 2 ]Safety & Efficacy: TEG002 pharmacodynamics measured by the ferritin level in serum over time
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688853
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 |
Responsible Party: | Gadeta B.V. |
ClinicalTrials.gov Identifier: | NCT04688853 |
Other Study ID Numbers: |
TEG002_MM_US_01 |
First Posted: | December 30, 2020 Key Record Dates |
Last Update Posted: | September 8, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
T cell therapy Engineered T Cells TEG TEGs TEG002 |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |