Multiple MyelomaPhase 1/2NCT03322735
Study of BCMA CAR-T in Multiple Myeloma
A Phase 1/2 study testing Fludarabine, Cyclophosphamide and BCMA CAR-T in people with Multiple Myeloma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to infusion BCMA CAR-T 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 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fludarabine, Cyclophosphamide and BCMA CAR-T
- 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
- 8 Dec 2017to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18 years to 70 years, expected survival > 3 months;
- 2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- 3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；
- 4. ECOG performance status of 0-2;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;
- 6. No serious allergic constitution;
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- 7. No other serous diseases that conflicts with the clinical program;
- 8. No other cancer history;
- 9. female participants of reproductive potential must have a negative serum pregnancy test;
- 10. Subjects must have signed written, informed consent.
Who cannot join
- 1. Pregnant or lactating women;
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. serious mental disorder;
- 6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- 7. 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
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan
Yongping Song, +86-13521186987, ph200811@163.com
Yongping Song
About this study
Official title: A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
- Conditions
- Multiple Myeloma
- Being tested
- Fludarabine, Cyclophosphamide, BCMA CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
25-30mg/m2/day IV for 3 days
CyclophosphamideDrug
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days
BCMA CAR-TBiological
BCMA CAR-T cells will be administered after completion of the chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| anti-tumor response of BCMA CAR-T | Experimental | Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.
Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
number of participants with adverse events
Measured: 1 year
Secondary outcomes (2)
Persistence of the BCMA CAR+ T cells
determine duration of in vivo survival of BCMA CAR-T cells
Measured: 1 year
anti-tumor responses of BCMA CAR-T cells
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 posted26 Oct 2017
- Study start8 Dec 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2019 (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 Henan Cancer HospitalThe 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 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
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Responsible party
- Sponsor
- Investigators
- Yongping Song, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322735
- Sponsor's protocol ID
- HenanCH284
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03322735
- Acronym / sponsor ID
- HenanCH284
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Oct 2017 (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 infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition 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-T | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: BCMA CAR-TDrug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. 18 years to 70 years, expected survival > 3 months;
- 2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- 3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；
- 4. ECOG performance status of 0-2;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;
Key exclusion criteria (7 listed)
- 1. Pregnant or lactating women;
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. 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 |
|---|---|---|
| Fludarabine25-30mg/m2/day IV for 3 days | Drug | anti-tumor response of BCMA CAR-T |
| Cyclophosphamidecyclophosphamide 0.6-0.8g/m2/day IV for 2 days | Drug | anti-tumor response of BCMA CAR-T |
| BCMA CAR-TBCMA CAR-T cells will be administered after completion of the chemotherapy. | Biological | anti-tumor response of BCMA CAR-T |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 year
number of participants with adverse events
2 secondary outcomes
Persistence of the BCMA CAR+ T cells
Time frame: 1 year
anti-tumor responses of BCMA CAR-T cells
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
Yongping Song principal investigator
Henan Cancer 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 Fludarabine, Cyclophosphamide and BCMA CAR-T in people with Multiple Myeloma, run by Henan Cancer 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 10 inclusion and 7 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 29 Dec 2017. 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 Yongping Song (+86-13521186987, ph200811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 1 year). 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 29 Dec 2017.