Multiple MyelomaPhase 1/2NCT05150522
B Cell Maturation Antigen Targeted CAR-T Cells in Treatment With Relapsed and Refractory Multiple Myeloma
A Phase 1/2 study testing BCMA CAR-T cells in people with Multiple Myeloma and Relapse Multiple Myeloma, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Relapse Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- BCMA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Jul 2024
- Phase
- Phase 1/2
- 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
- Age 18-75 (≥18, ≤75) one year old, no gender limit;
- The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
- Definitely diagnosed as relapsed or refractory multiple myeloma: use chemotherapy regimens containing bortezomib, or chemotherapy regimens containing lenalidomide, the treatment is ineffective, or the disease progresses within 60 days after the end of the last chemotherapy;
- The patient has one or more measurable multiple myeloma lesions, which must include any of the following:
- 1) Serum M protein is greater than or equal to 0.5g / dl (10g / l) 2) Urine M protein is greater than or equal to 200 mg / 24 h serum FLC ratio is abnormal 3) Serum free light chain (FLC) ≧5 mg / dL (50 mg /L) 4) Plasmacytoma that can be measured by physical examination or imaging examination 5) Myeloma cells in bone marrow ≧10% by flow cytometry or immunohistochemical examination 5. After flow cytometry or immunohistochemical examination, myeloma cells have positive BCMA expression; 6. No salvage chemotherapy was used within 4 weeks before cell therapy; 7. Within 2 weeks before cell therapy, have not received antibody drug therapy; 8. The ECOG score is 0-2 points; 9. The subject has no contraindications to peripheral blood apheresis; 10. The expected survival period is ≧12 weeks; 11. Female subjects of childbearing age must have a negative urine pregnancy test within 7 days prior to cell therapy and not during the lactation period; female or male subjects of childbearing age must take effective contraceptive measures throughout the study.
Who cannot join
- Those who have a history of allergies to any of the ingredients in cell products;
- The following conditions in laboratory tests: including but not limited to serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl; hemoglobin <80g/ l; does not rely on GCSF or other growth factors, the absolute neutrophil count is less than 1000 / mm3; no blood transfusion is required, and the platelet count is less than 30,000 / mm3;
- According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) <50%;
- Abnormal lung function, blood oxygen saturation in indoor air <92%;
- Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious clinical heart diseases within 12 months before enrollment;
- Hypertension is grade 3 and the blood pressure is not well controlled by medication;
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- Patients with prolonged QT interval on ECG, patients with severe heart disease such as severe arrhythmia in the past;
- Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Need to use any anticoagulant (except aspirin);
- Patients who need urgent treatment due to tumor progression or spinal cord compression;
- Patients with CNS metastasis or CNS involvement symptoms (including cranial neuropathy and extensive disease or spinal cord compression);
- The investigator determines that there are serious complications or diseases that increase the risk of the subject or affect the research, including but not limited to, for example: liver cirrhosis, recent major trauma, etc.;
- After allogeneic hematopoietic stem cell transplantation;
- Plasma cell leukemia;
- Before apheresis and within 2 weeks before CAR-T cell infusion, apply more than 5 mg/d of prednisone (or an equivalent amount of other corticosteroids);
- Patients with autoimmune diseases, immunodeficiencies or other patients who need immunosuppressive therapy;
- There is an uncontrolled active infection;
- Have used any CAR-T cell products or other genetically modified T cell therapies before;
- Live vaccination within 4 weeks before enrollment;
- HIV, HBV, HCV and TPPA/RPR infected persons, and HBV carriers;
- The subject has a history of alcoholism, drug abuse or mental illness;
- The subject has participated in any other clinical research within 3 months before joining this clinical research;
- The researcher believes that the subjects have other conditions that are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Li Yu
Shenzhen, Guangdong, 518000
Li Yu, +8675521839178, liyu_gcp@163.com
About this study
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.
Read the detailed description
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.
BCMA (B cell maturation antigen), also called TNFRSF17 (TNF receptor superfamily member 17, TNF ligand superfamily member 17), is mainly expressed in plasma cells and mature B lymphocytes, is basically undetectable in other normal human cells . BCMA is the most selectively expressed receptor on the MM cell line, and its expression gradually increases with the differentiation of B cells, and it also gradually increases in the disease process of multiple myeloma. Experiments in mice found that overexpression of BCMA can induce protein kinase B, mitogen-activated protein kinase (MAPK) and nuclear factor kB (nuclear factors kB, NF-kB) signal cascade to enhance the growth and survival of MM cells, thereby Speed up the progress of MM; and down-regulation of BCMA expression can significantly reduce the formation of MM colonies and reduce the survival rate of MM cells. BCMA has become an ideal antigen target for MM because of its high selective expression in MM cell lines and its important role in normal and malignant late B cell proliferation, differentiation and antibody production.
- Being tested
- BCMA CAR-T cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CAR-T cellsBiological
BCMA CAR-T cells infusion
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-T | Experimental | BCMA CAR-T cells infusion Receives: Biological: BCMA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free-Survival
Measured: From data of enrollment until the data of first documented progression, up to 2 years.
Secondary outcomes (1)
OS
Overall Survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jul 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YuLi, Shenzhen University General Hospital
- Investigators
- Li Yu, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150522
- Sponsor's protocol ID
- HEM-ONCO-012
- Status last verified
- Jul 2021
- First submitted
- 22 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B Cell Maturation Antigen Targeted CAR-T Cells in Treatment With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05150522
- Acronym / sponsor ID
- HEM-ONCO-012
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 9 Dec 2021 (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.
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.
Detailed description
For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.
BCMA (B cell maturation antigen), also called TNFRSF17 (TNF receptor superfamily member 17, TNF ligand superfamily member 17), is mainly expressed in plasma cells and mature B lymphocytes, is basically undetectable in other normal human cells . BCMA is the most selectively expressed receptor on the MM cell line, and its expression gradually increases with the differentiation of B cells, and it also gradually increases in the disease process of multiple myeloma. Experiments in mice found that overexpression of BCMA can induce protein kinase B, mitogen-activated protein kinase (MAPK) and nuclear factor kB (nuclear factors kB, NF-kB) signal cascade to enhance the growth and survival of MM cells, thereby Speed up the progress of MM; and down-regulation of BCMA expression can significantly reduce the formation of MM colonies and reduce the survival rate of MM cells. BCMA has become an ideal antigen target for MM because of its high selective expression in MM cell lines and its important role in normal and malignant late B cell proliferation, differentiation and antibody production.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-T | Experimental | Biological: BCMA CAR-T cellsBCMA CAR-T cells infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 (≥18, ≤75) one year old, no gender limit;
- The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
- Definitely diagnosed as relapsed or refractory multiple myeloma: use chemotherapy regimens containing bortezomib, or chemotherapy regimens containing lenalidomide, the treatment is ineffective, or the disease progresses within 60 days after the end of the last chemotherapy;
- The patient has one or more measurable multiple myeloma lesions, which must include any of the following:
- 1) Serum M protein is greater than or equal to 0.5g / dl (10g / l) 2) Urine M protein is greater than or equal to 200 mg / 24 h serum FLC ratio is abnormal 3) Serum free light chain (FLC) ≧5 mg / dL (50 mg /L) 4) Plasmacytoma that can be measured by physical examination or imaging examination 5) Myeloma cells in bone marrow ≧10% by flow cytometry or immunohistochemical examination 5. After flow cytometry or immunohistochemical examination, myeloma cells have positive BCMA expression; 6. No salvage chemotherapy was used within 4 weeks before cell therapy; 7. Within 2 weeks before cell therapy, have not received antibody drug therapy; 8. The ECOG score is 0-2 points; 9. The subject has no contraindications to peripheral blood apheresis; 10. The expected survival period is ≧12 weeks; 11. Female subjects of childbearing age must have a negative urine pregnancy test within 7 days prior to cell therapy and not during the lactation period; female or male subjects of childbearing age must take effective contraceptive measures throughout the study.
Key exclusion criteria (23 listed)
- Those who have a history of allergies to any of the ingredients in cell products;
- The following conditions in laboratory tests: including but not limited to serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl; hemoglobin <80g/ l; does not rely on GCSF or other growth factors, the absolute neutrophil count is less than 1000 / mm3; no blood transfusion is required, and the platelet count is less than 30,000 / mm3;
- According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) <50%;
- Abnormal lung function, blood oxygen saturation in indoor air <92%;
- Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious clinical heart diseases within 12 months before enrollment;
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 |
|---|---|---|
| BCMA CAR-T cellsBCMA CAR-T cells infusion | Biological | BCMA CAR-T |
Primary outcome
PFS
Time frame: From data of enrollment until the data of first documented progression, up to 2 years.
Progression-Free-Survival
1 secondary outcome
OS
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Li Yu principal investigator
Shenzhen University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BCMA CAR-T cells in people with Multiple Myeloma and Relapse Multiple Myeloma, run by Shenzhen University General Hospital 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 5 inclusion and 23 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 9 Dec 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yu (+8675521839178, liyu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From data of enrollment until the data of first documented progression, up to 2 years.). 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 9 Dec 2021.