Multiple MyelomaEarly Phase 1NCT03943472
BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing Anti-BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Hrain Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Anti-BCMA CAR-T cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2019to May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected survival > 12 weeks
- Diagnosis of Multiple Myeloma by MWG criteria 20
- Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
- Important organs function enough to tolerate this therapy
- At least 90 days after stem cell transplantation
- Accessible to intravenous injection, and no white blood cell collection contraindications
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
- Able to understand and sign the Informed Consent Document.
Who cannot join
- Patients with symptoms of central nervous system
- Patients with second malignancies in addition to multiple myeloma
- Active hepatitis B or C, HIV infections
- Any other active diseases could affect the enrollment of this trial
- Suffering severe cardiovascular or respiratory disease
- Poorly controlled hypertension
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- Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
- A history of mental illness and poorly controlled
- Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
- Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
- Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Active systemic infections or uncontrolled infection within 14 days prior enrollment
- Subjects suffering disease affects the understanding of informed consent or complying with study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Wei J Fu, Professor, 021-81885423, fuweijun2010@hotmail.com
About this study
Official title: A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
Read the detailed description
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
- Conditions
- Multiple Myeloma
- Being tested
- Anti-BCMA CAR-T cells, Fludarabine, Cyclophosphamide, Immune inhibitors
- Keywords
- BCMA, CAR-T, multiple myeloma, Relapsed /Refractory
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BCMA CAR-T cellsBiological
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
FludarabineDrug
30mg/m2/d
CyclophosphamideDrug
300mg/m2/d
Immune inhibitorsDrug
Immune inhibitors
| Study group | Role | What they receive |
|---|---|---|
| anti-BCMA CAR-T | Experimental | Administration of anti-BCMA CAR-T cells to patients with multiple myeloma Receives: Biological: Anti-BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| anti-BCMA CAR-T+ Immune inhibitors | Experimental | Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma Receives: Biological: Anti-BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Immune inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Measured: 6 months
Secondary outcomes (2)
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Measured: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 Jul 2019
- Primary completionNov 2021 (estimated)
- Study completionMay 2022 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hrain Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943472
- Sponsor's protocol ID
- anti-BCMA CART
- Status last verified
- Aug 2021
- First submitted
- 7 May 2019
- Last updated
- 31 Aug 2021
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03943472
- Acronym / sponsor ID
- anti-BCMA CART
- Conditions
- Multiple Myeloma
- Keywords
- BCMA, CAR-T, multiple myeloma, Relapsed /Refractory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hrain Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 9 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 goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
Detailed description
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-BCMA CAR-T | Experimental | Biological: Anti-BCMA CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideAdministration of anti-BCMA CAR-T cells to patients with multiple myeloma |
| anti-BCMA CAR-T+ Immune inhibitors | Experimental | Biological: Anti-BCMA CAR-T cells, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Immune inhibitorsAdministration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Expected survival > 12 weeks
- Diagnosis of Multiple Myeloma by MWG criteria 20
- Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
- Important organs function enough to tolerate this therapy
- At least 90 days after stem cell transplantation
Key exclusion criteria (14 listed)
- Patients with symptoms of central nervous system
- Patients with second malignancies in addition to multiple myeloma
- Active hepatitis B or C, HIV infections
- Any other active diseases could affect the enrollment of this trial
- Suffering severe cardiovascular or respiratory disease
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 |
|---|---|---|
| Anti-BCMA CAR-T cellsRetroviral vector-transduced autologous T cells to express anti-BCMA CAR | Biological | anti-BCMA CAR-T, anti-BCMA CAR-T+ Immune inhibitors |
| Fludarabine30mg/m2/d | Drug | anti-BCMA CAR-T, anti-BCMA CAR-T+ Immune inhibitors |
| Cyclophosphamide300mg/m2/d | Drug | anti-BCMA CAR-T, anti-BCMA CAR-T+ Immune inhibitors |
| Immune inhibitorsImmune inhibitors | Drug | anti-BCMA CAR-T+ Immune inhibitors |
Primary outcome
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Time frame: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
2 secondary outcomes
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- 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 Early Phase 1 study testing Anti-BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Hrain Biotechnology 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 8 inclusion and 14 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 31 Aug 2021. 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 Xuedong Sun (021-58552006, sunxuedong@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 (time frame: 6 months). 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 31 Aug 2021.