Relapsed and Refractory Multiple MyelomaEarly Phase 1BCMA CAR-TNCT03661554
BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma
A Early Phase 1 study testing BCMA CAR-T Cells in people with Relapsed and Refractory Multiple Myeloma, run by The Pregene (ShenZhen) Biotechnology Company, Ltd. at 1 site in China.
Trial summary
This clinical study is an exploratory study, mainly to study the safety and efficacy of BCMA nano-antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 7.5 x 106 / kg and 1.5 x 107 / kg, were divided into three groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed and Refractory Multiple Myeloma
- What is being tested?
- BCMA CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2018to 30 Nov 2018
- Phase
- Early 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years, the expected survival time is greater than 3 months;
- Active MM was diagnosed, BCMA positive;
- At present, there is no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation, or patients voluntarily choose to infuse anti-BCMA nano-antibody CAR-T cells as the first treatment;
- ECOG : 0-2 points;
- Cardiac function: no heart disease or coronary heart disease, cardiac function 1-2;
- Liver function: TBIL < 3 ULN, AST < 2.5 ULN, ALT < 2.5 ULN;
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- Renal function: Cr < 1.25 ULN;
- Patients with smooth peripheral venous access can meet the needs of intravenous drip;
- There are no other serious diseases (such as autoimmune diseases, immunodeficiency and organ transplantation) that are inconsistent with this protocol;
- There was no history of malignancy;
- Women of childbearing age must be tested for negative blood pregnancy tests within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial;
- Patients agreed to participate in the clinical study and signed the informed consent form.
Who cannot join
- Pregnant women or lactating women (women of childbearing age need to have a pregnancy check);
- Severe infectious diseases were found in the first 4 weeks of admission;
- Active hepatitis B or C viral hepatitis;
- HIV infected patients;
- Suffering from severe autoimmune or immunodeficiency diseases;
- Severe allergic constitution;
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- Severe mental disorders;
- Systematic overuse of glucocorticoids within the first four weeks of admission (except for inhaled corticosteroids);
- Suffering from severe heart, liver, renal insufficiency, diabetes and other diseases;
- In the past 3 months, he participated in other clinical studies or previous treatment of other gene products.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pregene Shenzhen Biotechnology Co., Ltd.
Shenzhen, Guangdong, 518000
jishuai zhang, 13661255147 ext. 13661255147, zhangjs@pregene.com
About this study
Official title: BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma
This clinical study is an exploratory study, mainly to study the safety and efficacy of BCMA nano-antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 7.5 x 106 / kg and 1.5 x 107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled.
Read the detailed description
The aim of this study is to study the safety and efficacy of BCMA nanoantibody CAR-T in the treatment of MM. BCMA CAR is composed of BCMA nano-antibody, CD8 strand region, transmembrane region and 4-1BB costimulatory domain, and CD3-_T cell activation domain. BCMA nano-antibody CAR-T cells were prepared by lentivirus infection of T cells. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled. After transfusion, adverse events were closely monitored and therapeutic effects were evaluated on the 28th day after transfusion. Follow-up was conducted every 6 weeks within 6 months and every 10 weeks after 6 months. To evaluate the safety and efficacy of BCMA nano antibody CAR-T in the treatment of refractory and relapsed MM.
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Being tested
- BCMA CAR-T Cells
- Medical subject headings
- Recurrence, 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
The Chinese name of CAR-T cells is chimeric antigen receptor T cells. It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | This clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design. The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups. Receives: Biological: BCMA CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start10 Apr 2018
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 1 x 107 / kg and 1.5 x 107 / kg, were divided into three groups.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661554
- Sponsor's protocol ID
- PRG 1801
- Acronym
- BCMA CAR-T
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma
- ClinicalTrials.gov ID
- NCT03661554
- Acronym / sponsor ID
- BCMA CAR-T / PRG 1801
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Pregene (ShenZhen) Biotechnology Company, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 7 Sep 2018 (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 clinical study is an exploratory study, mainly to study the safety and efficacy of BCMA nano-antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 7.5 x 106 / kg and 1.5 x 107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled.
Detailed description
The aim of this study is to study the safety and efficacy of BCMA nanoantibody CAR-T in the treatment of MM. BCMA CAR is composed of BCMA nano-antibody, CD8 strand region, transmembrane region and 4-1BB costimulatory domain, and CD3-_T cell activation domain. BCMA nano-antibody CAR-T cells were prepared by lentivirus infection of T cells. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled. After transfusion, adverse events were closely monitored and therapeutic effects were evaluated on the 28th day after transfusion. Follow-up was conducted every 6 weeks within 6 months and every 10 weeks after 6 months. To evaluate the safety and efficacy of BCMA nano antibody CAR-T in the treatment of refractory and relapsed MM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 1 x 107 / kg and 1.5 x 107 / kg, were divided into three groups.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: BCMA CAR-T CellsThis clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design. The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-75 years, the expected survival time is greater than 3 months;
- Active MM was diagnosed, BCMA positive;
- At present, there is no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation, or patients voluntarily choose to infuse anti-BCMA nano-antibody CAR-T cells as the first treatment;
- ECOG : 0-2 points;
- Cardiac function: no heart disease or coronary heart disease, cardiac function 1-2;
Key exclusion criteria (10 listed)
- Pregnant women or lactating women (women of childbearing age need to have a pregnancy check);
- Severe infectious diseases were found in the first 4 weeks of admission;
- Active hepatitis B or C viral hepatitis;
- HIV infected patients;
- Suffering from severe autoimmune or immunodeficiency diseases;
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 CellsThe Chinese name of CAR-T cells is chimeric antigen receptor T cells. It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells. | Biological | single arm |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA CAR-T Cells in people with Relapsed and Refractory Multiple Myeloma, run by The Pregene (ShenZhen) Biotechnology Company, Ltd. 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 12 inclusion and 10 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 10 Sep 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 jishuai zhang, doctor (13661255147, zhangjs@pregene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 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 10 Sep 2018.