Multiple MyelomaPhase 1/2NCT03915184
Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
A Phase 1/2 study testing zevor-cel in people with Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd. at 13 sites in 2 countries.
Trial summary
A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- zevor-cel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 25 Sep 2019to 31 Dec 2034
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed consent;
- Age of ≥ 18 and < 80 years;
- Received sufficient prior lines of myeloma therapy;
- Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
- The patient must be refractory to the last line of therapy.
- The patients should have measurable disease per IMWG definition.
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- Estimated life expectancy > 12 weeks;
- ECOG performance score 0-1;
- Patients should have reasonable CBC counts, renal and hepatic functions;
- Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
- Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;
- Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.
Who cannot join
- Pregnant or lactating women;
- HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
- Any uncontrolled active infection;
- AEs from previous treatment that have not recovered;
- Patients who have had anti-BCMA therapy;
- Patients who have graft versus host disease (GvHD);
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- Patients have received stem cell transplantation one year before leukapheresis;
- Patients have received any anti-cancer treatment before leukapheresis;
- Patients have received steroids before leukapheresis or lymphodepletion;
- Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;
- Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion;
- Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or zevor-cel CAR BCMA T cell;
- Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
- Patients have clinical significant pulmonary conditions;
- Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
- Patients with second malignancies in addition to MM are not eligible;
- Patients have central nervous system (CNS) metastases or CNS involvement;
- Patients have significant neurologic disorders;
- Patients are unable or unwilling to comply with the requirements of clinical trial;
- Patients have received major surgery prior to leukapheresis or prior to lymphodepletion.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Dana Farber Cancer Center
Boston, Massachusetts, 02215
UT Southwestern Medical Center
Dallas, Texas, 76021
Colorado Blood Cancer Institute
Denver, Colorado, 80218
MD Anderson
Houston, Texas, 77030
Methodist Hosptial
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
TriStar CMC
Nashville, Tennessee, 37203
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Mayo
Rochester, Minnesota, 55905
Huntsman Cancer Center
Salt Lake City, Utah, 84112
UCSF
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
Read the detailed description
This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma.
Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
- Conditions
- Multiple Myeloma
- Being tested
- zevor-cel
- Keywords
- CAR-T, Carcinoma, Carcinoma, Multiple Myeloma, CT053, zevor-cel
- Medical subject headings
- Multiple Myeloma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zevor-celBiological
Also called CAR-BCMA T Cell Infusion
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
| Study group | Role | What they receive |
|---|---|---|
| CAR-BCMA T Cells | Experimental | Phase 1b will include a dose escalation followed by an expansion cohort to determine the recommended dose for the expansion part. After recommended Phase 2 is determined, patients in Phase 2 will be treated. Receives: Biological: zevor-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Measured: Day 1 - Month 60
Identification of Maximum Tolerated Dose (MTD)
Incidence of dose-limiting toxicities (DLTs)
Measured: Day 1 - Month 60
Objective response rate
Objective response rate (ORR) per IMWG by IRC read
Measured: Day 1 - Month 60
Secondary outcomes (6)
Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM
Disease-specific response criteria including, but not limited to: complete response (CR), MRD, very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, Time to Response, Time to Progression, Progression Free Survival, best response and Overall Survival
Measured: Day 1 - Month 60
Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment
ORR, DOR, FPS, OS, MRD, time to response, time to progression, best tumor response
Measured: Day 1 - Month 60
Evaluate zevor-cel PK profile
CAR transgene copy number, peak value, AUC, in vivo persistence
Measured: Day 1 - Month 60
Evaluate ADA profile
Percentage of patients with anti-zevor-cel drug antibodies
Measured: Day 1 - Month 60
Evaluate HRQoL in patients with rrMM from baseline up to study completion
Change from baseline in HRQoL as measured by EORTC QLQ-C30 and QLQ-MY20
Measured: Day 1 - Month 60
Evaluate utilization of hospital resources
Duration of hospitalization and ICU
Measured: Day 1 - Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start25 Sep 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaji Kumar, MD, Principal investigator, Mayo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915184
- Sponsor's protocol ID
- CT053-MM-02 (LUMMICAR STUDY 2)
- Status last verified
- Dec 2023
- First submitted
- 3 Apr 2019
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
- ClinicalTrials.gov ID
- NCT03915184
- Acronym / sponsor ID
- CT053-MM-02 (LUMMICAR STUDY 2)
- Conditions
- Multiple Myeloma
- Keywords
- CAR-T, Carcinoma, Carcinoma, Multiple Myeloma, CT053, zevor-cel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 16 Apr 2019 (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.
A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
Detailed description
This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma.
Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-BCMA T Cells | Experimental | Biological: zevor-celPhase 1b will include a dose escalation followed by an expansion cohort to determine the recommended dose for the expansion part. After recommended Phase 2 is determined, patients in Phase 2 will be treated. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily signed consent;
- Age of ≥ 18 and < 80 years;
- Received sufficient prior lines of myeloma therapy;
- Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
- The patient must be refractory to the last line of therapy.
Key exclusion criteria (20 listed)
- Pregnant or lactating women;
- HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
- Any uncontrolled active infection;
- AEs from previous treatment that have not recovered;
- Patients who have had anti-BCMA therapy;
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 |
|---|---|---|
| zevor-celAlso: CAR-BCMA T Cell InfusionA single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion | Biological | CAR-BCMA T Cells |
Primary outcome
Incidence of Treatment Related adverse events (AEs)
Time frame: Day 1 - Month 60
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Identification of Maximum Tolerated Dose (MTD)
Time frame: Day 1 - Month 60
Incidence of dose-limiting toxicities (DLTs)
Objective response rate
Time frame: Day 1 - Month 60
Objective response rate (ORR) per IMWG by IRC read
6 secondary outcomes
Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM
Time frame: Day 1 - Month 60
Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment
Time frame: Day 1 - Month 60
Evaluate zevor-cel PK profile
Time frame: Day 1 - Month 60
Evaluate ADA profile
Time frame: Day 1 - Month 60
Evaluate HRQoL in patients with rrMM from baseline up to study completion
Time frame: Day 1 - Month 60
Evaluate utilization of hospital resources
Time frame: Day 1 - Month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Shaji Kumar, MD principal investigator
Mayo
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing zevor-cel in people with Multiple Myeloma, run by CARsgen Therapeutics Co., Ltd. at 13 sites in 2 countries.
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 12 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Treatment Related adverse events (AEs) (time frame: Day 1 - Month 60). The study lists 3 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 19 Dec 2023.