Multiple Myeloma in RelapsePhase 1/2NCT06644443
BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing BCMA-GPRC5D CAR-T cells in people with Multiple Myeloma in Relapse, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- BCMA-GPRC5D CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 14 Jul 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- The subject voluntarily participates in the research and signs the \"Informed Consent\" by himself or his legal guardian;
- 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
- After flow cytometry or immunohistochemical examination, myeloma cells have positive BCMA and GPRC5D expression;
- No salvage chemotherapy was used within 4 weeks before cell therapy;
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- No antibody drug therapy was used within 2 weeks before cell therapy;
- The ECOG score is 0-2 points;
- The subject has no contraindications to peripheral blood apheresis;
- The expected survival period is ≧12 weeks;
- 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;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen University General Hospital
Shenzhen, Guangdong
DiYa Cai, Doctor, 19831362517, sdzyllwyh@126.com
LiXin Wang, Doctor, 13718000488, Wanglixin1991@sohu.com
About this study
Official title: BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma：A Prospective, Single-center, Single-arm Phase I/IIa Clinical Trial
At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.
Read the detailed description
Multiple myeloma (MM) is a hematological malignant tumor characterized by clonal proliferation of abnormal plasma cells in the bone marrow. The incidence of MM is mainly in the middle and old age, and the incidence of MM in China has increased in recent years. At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Recurrent or refractory MM is still a thorny problem in the treatment of MM, which is an important factor for the survival of patients.Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- BCMA-GPRC5D CAR-T cells
- Keywords
- 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, Multiple Myeloma, Neoplasms, Plasma Cell
- Medical subject headings
- Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Cardiovascular Diseases, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA-GPRC5D CAR-T cellsBiological
patient was subjected to 2-5×10^6 BCMA-GPRC5D CAR-T cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Experimental：Treatment group | Experimental | patients treated with BCMA-GPRC5D CAR-T cells Receives: Biological: BCMA-GPRC5D CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Adverse events during treatment
Measured: From date of initial treatment to the 30 days after treatment
Secondary outcomes (1)
Disease-related clinical responses
Disease-related clinical responses include sCR/CR/VGPR/PR/MR/SD/PD
Measured: From data of enrollment until the data of clinical responses,up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Jul 2023
- Primary completion14 Jul 2025 (estimated)
- Study completion14 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies 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
- Sponsor
- Investigators
- Xiao Guo, Doctor, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644443
- Sponsor's protocol ID
- HEM-ONCO-028
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma：A Prospective, Single-center, Single-arm Phase I/IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT06644443
- Acronym / sponsor ID
- HEM-ONCO-028
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders, Vascular Diseases, Cardiovascular Diseases, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 14 Jul 2025 (estimated)
- Study completion
- 14 Jul 2026 (estimated)
- First posted
- 16 Oct 2024 (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.
At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.
Detailed description
Multiple myeloma (MM) is a hematological malignant tumor characterized by clonal proliferation of abnormal plasma cells in the bone marrow. The incidence of MM is mainly in the middle and old age, and the incidence of MM in China has increased in recent years. At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Recurrent or refractory MM is still a thorny problem in the treatment of MM, which is an important factor for the survival of patients.Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental：Treatment group | Experimental | Biological: BCMA-GPRC5D CAR-T cellspatients treated with BCMA-GPRC5D CAR-T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- The subject voluntarily participates in the research and signs the \"Informed Consent\" by himself or his legal guardian;
- 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
- After flow cytometry or immunohistochemical examination, myeloma cells have positive BCMA and GPRC5D expression;
Key exclusion criteria (22 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-GPRC5D CAR-T cellspatient was subjected to 2-5×10^6 BCMA-GPRC5D CAR-T cells/kg | Biological | Experimental：Treatment group |
Primary outcome
TEAEs
Time frame: From date of initial treatment to the 30 days after treatment
Adverse events during treatment
1 secondary outcome
Disease-related clinical responses
Time frame: From data of enrollment until the data of clinical responses,up to 2 years.
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 16 Oct 2024.
- 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.
Xiao Guo, Doctor 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-GPRC5D CAR-T cells in people with Multiple Myeloma in Relapse, 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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. 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?
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?
Contact Xiao Guo, Doctor (13722795969, guoxiao10267322@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs (time frame: From date of initial treatment to the 30 days after treatment). 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 16 Oct 2024.