Multiple MyelomaPhase 1/2NCT03940833
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
A Phase 1/2 study testing BCMA CAR-NK 92 cells in people with Multiple Myeloma, run by Asclepius Technology Company Group (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA CAR-NK 92 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2019to May 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 80 years, expected survival > 3 months
- Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
- BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
- ECOG performance status of 0 - 1
- Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
- No serious allergic constitution
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- No other serous diseases that conflicts with the clinical program
- No other cancer history
- Female participants of reproductive potential must have a negative serum pregnancy test
- Subjects must have signed written, informed consent
Who cannot join
- Pregnant or lactating women
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- Serious mental disorder
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
- Participate in other clinical research in the past three months
- Previously treatment with any gene therapy products
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Wuxi People's Hospital, Nanjing Medical University
Wuxi, Jiangsu, 214000
Xin Zhou, PhD, 13358111962@qq.com
About this study
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA CAR-NK 92 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-NK 92 cellsBiological
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| anti-tumor response of BCMA CAR-NK-92 | Experimental | Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells. Receives: Biological: BCMA CAR-NK 92 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asclepius Technology Company Group (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940833
- Sponsor's protocol ID
- AsclepiusTCG02
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.
PubMed 34471234
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
- ClinicalTrials.gov ID
- NCT03940833
- Acronym / sponsor ID
- AsclepiusTCG02
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asclepius Technology Company Group (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 7 May 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.
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-tumor response of BCMA CAR-NK-92 | Experimental | Biological: BCMA CAR-NK 92 cellsPatients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years to 80 years, expected survival > 3 months
- Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
- BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
- ECOG performance status of 0 - 1
- Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- Serious mental disorder
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-NK 92 cellsThe subject will be observed for any side effects during this time and all the adverse events will be recorded. | Biological | anti-tumor response of BCMA CAR-NK-92 |
Primary outcome
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Time frame: 1 year
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Derived from this study: PubMed 34471234Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.
- 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.
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-NK 92 cells in people with Multiple Myeloma, run by Asclepius Technology Company Group (Suzhou) Co., 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 10 inclusion and 8 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 7 May 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 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 Guangfu Li (+86 13615181959, lgf@atcgcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related adverse events as assessed by CTCAE v4.03 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940833, which also lists 1 linked publication.
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 7 May 2019.