Relapsed or Refractory Multiple MyelomaEarly Phase 1NCT04626752
CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Early Phase 1 study testing BCMA CAR-T, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This study is aimed to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- BCMA CAR-T, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Mar 2023
- 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
- The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
- According to the international standard for multiple myeloma (IMWG 2014);
- Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow.
- Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
- The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
- No antibody drug was administered within last 2 weeks before cell therapy;
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- ECOG Scores: 0~1
- Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
- The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥92%;
- There was no contraindication for peripheral blood sampling;
- The estimated survival time was more than 12 weeks;
- The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; the female or male subjects of childbearing age should take effective contraceptive measures during the whole research process.
Who cannot join
- Have a history of allergy to any component of cell products;
- There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
- who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Patients who need urgent treatment due to tumor progression or spinal cord compression;
- The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
- After allogeneic hematopoietic stem cell transplantation;
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- Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive（excluding glucocorticoid）therapy;
- There was uncontrolled active infection;
- There were live vaccinations within 4 weeks before admission;
- Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
- Subjects had a history of alcohol, drug or mental illness;
- The researchers believe that there are other conditions that subjects are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
Jianmin Luo, PhD&MD contact
China1 site, 1 recruiting
- Recruiting
the Second Hospital of HeBei Medical University (HBMU)
Shijiazhuang, Hebei, 050000
Jianqiang Li, MD, 86-311-82970975, hr@senlangbio.com
About this study
Official title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Multiple Myeloma (MM)
This study is aimed to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma
Read the detailed description
This is a study to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma.
The Main research objectives:
To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
The Secondary research objectives:
To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- BCMA CAR-T, Fludarabine, Cyclophosphamide
- 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-TDrug
Also called senl_BCMA
Volunteers will be treated with BCMA CAR-T cells
FludarabineDrug
Also called flu
25mg/㎡ for D-4、D-3 and D-2
CyclophosphamideDrug
Also called ctx
500mg/㎡ for D-3 and D-2
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Experimental | The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) Multiple Myeloma (MM) Receives: Drug: BCMA CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Measured: 28 days
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Measured: 24 months
Secondary outcomes (2)
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Measured: 24 months
Overall survival time
Overall survival time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Luo, PhD&MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626752
- Sponsor's protocol ID
- CAR-T for Multiple myeloma
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT04626752
- Acronym / sponsor ID
- CAR-T for Multiple myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 13 Nov 2020 (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 study is aimed to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma
Detailed description
This is a study to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma.
The Main research objectives:
To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
The Secondary research objectives:
To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Drug: BCMA CAR-T, Drug: Fludarabine, Drug: CyclophosphamideThe patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) Multiple Myeloma (MM) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
- According to the international standard for multiple myeloma (IMWG 2014);
- Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow.
- Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
- The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
Key exclusion criteria (12 listed)
- Have a history of allergy to any component of cell products;
- There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
- who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Patients who need urgent treatment due to tumor progression or spinal cord compression;
- The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
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-TAlso: senl_BCMAVolunteers will be treated with BCMA CAR-T cells | Drug | volunteers |
| FludarabineAlso: flu25mg/㎡ for D-4、D-3 and D-2 | Drug | volunteers |
| CyclophosphamideAlso: ctx500mg/㎡ for D-3 and D-2 | Drug | volunteers |
Primary outcome
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
Number of Participants with Severe/Adverse Events as a Measure of Safety
CAR-T Cell expansion level
Time frame: 24 months
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
2 secondary outcomes
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Jianmin Luo, PhD&MD contact
Jianmin Luo, PhD&MD principal investigator
The Second Hospital of Hebei Medical University
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, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., 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 12 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 13 Nov 2020. 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 Jianqiang Li, PhD&MD (+8631189928689, limmune@gmail.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 Severe/Adverse Events as a Measure of Safety (time frame: 28 days). The study lists 2 primary outcomes in all. 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 13 Nov 2020.