Multiple MyelomaPhase 2NCT03931421
B Cell Maturation Antigen（BMCA）-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma
A Phase 2 study testing CAR-T treatment in people with Multiple Myeloma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen（BMCA）-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CAR-T treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2019to 31 Dec 2022
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age≥18，male or female;
- 2. ECOG 0-3;
- 3. Clearly diagnosed as multiple myeloma (MM) [according to IMWG 2014 criteria];
- 4. Patients should have received 3 different regimens prior to enrollment (each regimen should last for at least one complete cycle, except for the case of disease progression);
- 5. Previously received one PI and IMiD treatment;
- 6. MM patients should fit one of the following: 1) disease progression; 2) relapsed after CR. The corresponding criteria is defined as follows: a, disease progression should satisfy at least 1 of the following: serum M protein ≥0.5g/dl, or urine M protein>200mg/24h, or FLC increasement >10mg/dl, or bone marrow plasma cell proportion >10%, or with new bone disease/plasmacytoma/original focus increased by 50% or more, or hypercalcemia ( corrected serum calcium level >11.5mg/dL(2.65mmol/L); b. relapse after CR, should satisfy one of the following: ①M protein in urine or blood; ②bone marrow plasma cell proportion≥5%; ③manifestation of disease progression, such as plasmacytoma, osteolytic lesions or hypercalcemia.
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- 7. Peripheral blood mononucleated cell separation should be at least 2 weeks from chemo/radiotherapy;
- 8. Neutrophil count≥1000/ul, platelet count≥45000/ul, Hb>60g/l;
- 9. Cardiac, hepatic and renal function: Creatinin <1.5 times of normal maximum；ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of ULN；cardiac ejection fraction≥ 50%; no pericardial effusion within 6 weeks prior to enrollment;
- 10. Being able to understand and willing to sign the written consent;
- 11. Fertile patients should agree to take contraceptive measures during the process of this trial.
Who cannot join
- 1. History of other tumors other than multiple myeloma, except for the following: malignant tumor after radical surgery, and have been inactive for ≥3 years prior to enrollment; skin cancer (not melanoma) after sufficient treatment, no evidence of disease at enrollment;
- 2. History of the following treatment: received targeted therapy, epigenetic therapy or clinical trials, invasive operation within 14 days/5 half-time prior to enrollment. History of monoclonal antibody within 21 days prior to enrollment. History of cytotoxic medicine or proteasome treatment within 14 days prior to enrollment. History of immunomodulatory treatment within 7 days prior to enrollment;
- 3. History of >5mg/d systemic prednisone treatment (or other glucocorticoids of the equivalent dosage) within 2 weeks prior to peripheral mononucleated cell collection;
- 4. With CNS involvement or clinical manifestation of meningeal myeloma;
- 5. With active systemic infection;
- 6. With active HBV infection or HCV infection, or history of type C hepatitis;
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- 7. With immunodeficiency, including HIV infection;
- 8. With the following heart condition: NYHA level III or IV congestive heart failure; myocardial infarction or CABG within 6 months prior to enrollment; clinically meaningful ventricular arrythmia, or history of idiopathic syncope (not caused by vascular-vagal disorder or dehydration), history of non-ischemic myopathy;
- 9. With active autoimmune disease;
- 10. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
- 11. History of allogenic stem cell transplantation.
Trial locations and contacts
1 site in 1 country.
Hui Liu, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Wenbin Qian, MD,PhD, (+86)13605801032, qianwenb@aliyun.com
About this study
It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen（BMCA）-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients.
Read the detailed description
In this trial, T cells are seperated from multiple myeloma patients, and engineered into BMCA-targeted CAR-T cells, these cells are then transfused back into the patients to elimimnate the myeloma cells. In this process, the safety and efficacy of this CAR-T treatment are closely monitored.
- Conditions
- Multiple Myeloma
- Being tested
- CAR-T treatment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T treatmentBiological
a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen（BMCA）-Targeted CAR-T cells to eliminate myeloma cells.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | In this arm, patients are treated with B Cell Maturation Antigen (BMCA)-targeted CAR-T cells and the safety and efficacy will be observed. Receives: Biological: CAR-T treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
complete remission rate after treated by CAR-T therapy
Measured: at the time point 3 months after CAR-T cell transfusion
incidence and severity of adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: from the date of the start of treatment to 36 months after last patient's enrollment
Secondary outcomes (3)
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment
duration of the CAR-T cells in the patients
time from re-transfusion to date when the modified T cells become non-detectable
Measured: from the date of re-transfusison to 36 months after last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start31 Jul 2019 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this trial, T cells were seperated from refractory/relapsed multiple myeloma patients and engineered into BMCA-targeted CAR-T cells, and then transfused back into the patients for the treatment of their multiple myeloma.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Qian, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931421
- Sponsor's protocol ID
- lymphoma center Q004
- Status last verified
- Jun 2019
- First submitted
- 25 Apr 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data would be available on the website of the affiliated hospital after the trial is completed
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B Cell Maturation Antigen（BMCA）-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03931421
- Acronym / sponsor ID
- lymphoma center Q004
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 31 Jul 2019 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 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.
It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen（BMCA）-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients.
Detailed description
In this trial, T cells are seperated from multiple myeloma patients, and engineered into BMCA-targeted CAR-T cells, these cells are then transfused back into the patients to elimimnate the myeloma cells. In this process, the safety and efficacy of this CAR-T treatment are closely monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this trial, T cells were seperated from refractory/relapsed multiple myeloma patients and engineered into BMCA-targeted CAR-T cells, and then transfused back into the patients for the treatment of their multiple myeloma.
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Biological: CAR-T treatmentIn this arm, patients are treated with B Cell Maturation Antigen (BMCA)-targeted CAR-T cells and the safety and efficacy will be observed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age≥18，male or female;
- 2. ECOG 0-3;
- 3. Clearly diagnosed as multiple myeloma (MM) [according to IMWG 2014 criteria];
- 4. Patients should have received 3 different regimens prior to enrollment (each regimen should last for at least one complete cycle, except for the case of disease progression);
- 5. Previously received one PI and IMiD treatment;
Key exclusion criteria (11 listed)
- 1. History of other tumors other than multiple myeloma, except for the following: malignant tumor after radical surgery, and have been inactive for ≥3 years prior to enrollment; skin cancer (not melanoma) after sufficient treatment, no evidence of disease at enrollment;
- 2. History of the following treatment: received targeted therapy, epigenetic therapy or clinical trials, invasive operation within 14 days/5 half-time prior to enrollment. History of monoclonal antibody within 21 days prior to enrollment. History of cytotoxic medicine or proteasome treatment within 14 days prior to enrollment. History of immunomodulatory treatment within 7 days prior to enrollment;
- 3. History of >5mg/d systemic prednisone treatment (or other glucocorticoids of the equivalent dosage) within 2 weeks prior to peripheral mononucleated cell collection;
- 4. With CNS involvement or clinical manifestation of meningeal myeloma;
- 5. With active systemic infection;
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 |
|---|---|---|
| CAR-T treatmenta novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen（BMCA）-Targeted CAR-T cells to eliminate myeloma cells. | Biological | experiment group |
Primary outcome
complete remission rate
Time frame: at the time point 3 months after CAR-T cell transfusion
complete remission rate after treated by CAR-T therapy
incidence and severity of adverse events
Time frame: from the date of the start of treatment to 36 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
3 secondary outcomes
progression free survival
Time frame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment
overall survival
Time frame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment
duration of the CAR-T cells in the patients
Time frame: from the date of re-transfusison to 36 months after last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: Yes. All the data would be available on the website of the affiliated hospital after the trial is completed
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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.
Hui Liu, MD,PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAR-T treatment in people with Multiple Myeloma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 11 inclusion and 11 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Qian, MD,PhD ((+86)13605801032, qianwenb@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: at the time point 3 months after CAR-T cell transfusion). 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 4 Jun 2019.