Multiple Myeloma, RefractoryPhase 1NCT04688853
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
A Phase 1 study testing TEG002 in people with Multiple Myeloma, Refractory and Multiple Myeloma in Relapse, run by Gadeta B.V. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Refractory, Multiple Myeloma in Relapse, Multiple Myeloma
- What is being tested?
- TEG002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 May 2021to 30 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
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.
- Being tested
- TEG002
- Keywords
- T cell therapy, Engineered T Cells, TEG, TEGs, TEG002
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG002Biological
TEG002 cells are autologous T cells transduced with a specific γδTCR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: TEG002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Until year 2
Secondary outcomes (11)
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
Measured: 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
Measured: Until Year 2
TEG002 efficacy by looking at Overall survival
Efficacy: Overall survival
Measured: Until Year 2
TEG002 efficacy by looking at Progression free survival
Efficacy: Progression free survival
Measured: Until Year 2
TEG002 efficacy by looking at Duration of response
Efficacy: Duration of response
Measured: Until Year 2
TEG002 efficacy by looking at Time to response
Efficacy: Time to response
Measured: Until Year 2
TEG002 efficacy by looking at Time to progression
Efficacy: Time to progression
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: until Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start13 May 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadeta B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688853
- Sponsor's protocol ID
- TEG002_MM_US_01
- Status last verified
- Sep 2022
- First submitted
- 21 Dec 2020
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT04688853
- Acronym / sponsor ID
- TEG002_MM_US_01
- Keywords
- T cell therapy, Engineered T Cells, TEG, TEGs, TEG002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gadeta B.V.Industry (pharma, biotech, devices)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, Open label | Experimental | Biological: TEG002This 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Adult
- Relapsed or refractory Multiple Myeloma as defined by the IMWG
- Life expectancy ≥3 months
- ECOG performance status 0 or 1
Key exclusion criteria (12 listed)
- Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
- Pregnant or lactating women
- Amyloidosis
- Uncontrolled infection(s)
- Active CNS disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEG002TEG002 cells are autologous T cells transduced with a specific γδTCR | Biological | Single Arm, Open label |
Primary outcome
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
11 secondary outcomes
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
TEG002 efficacy by looking at Objective response rate
Time frame: Until Year 2
TEG002 efficacy by looking at Overall survival
Time frame: Until Year 2
TEG002 efficacy by looking at Progression free survival
Time frame: Until Year 2
TEG002 efficacy by looking at Duration of response
Time frame: Until Year 2
TEG002 efficacy by looking at Time to response
Time frame: Until Year 2
TEG002 efficacy by looking at Time to progression
Time frame: Until Year 2
TEG002 pharmacokinetics measured in blood in bone marrow over time
Time frame: Until Year 2
TEG002 pharmacodynamics as measured by IL6 level in serum over time
Time frame: until Year 2
TEG002 pharmacodynamics as measured by CRP level in serum over time
Time frame: until Year 2
TEG002 pharmacodynamics as measured by ferritin level in serum over time
Time frame: until Year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Related trials for Multiple Myeloma, Refractory
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TEG002 in people with Multiple Myeloma, Refractory and Multiple Myeloma in Relapse, run by Gadeta B.V. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.