Multiple MyelomaNCT03752541
Efficacy and Safety Evaluation of BCMA-UCART
A study testing BCMA-UCART in people with Multiple Myeloma, run by Bioray Laboratories at 1 site in China.
Trial summary
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA-UCART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 20 Nov 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
- Subjects according with any of the following options:
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- Age≥50;
- Failure with separation of T cells during autologous CART processing; or,
- Failure with expansion of autologous CART; or,
- The proportion of T cells in PBMC <10%; or,
- Won't benefit from autologous CART therapy because of disease progress.
Who cannot join
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
- serious mental disorder;
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- 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
- Contraindication to cyclophosphamide or fludarabine chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Evaluation of BCMA-UCART（Allogeneic Engineered T-cells Expressing Anti-BCMA Chimeric Antigen Receptor）in the Treatment of Relapsed or Refractory Multiple Myeloma
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA-UCART
- 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-UCARTBiological
A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.
| Study group | Role | What they receive |
|---|---|---|
| BCMA-UCART | Experimental | Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW. Receives: Biological: BCMA-UCART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
Measured: Up to 90 days after T cell infusion
Secondary outcomes (2)
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Measured: Up to 35 days after T cell infusion
Duration of persistence of BCMA-UCART
Detect the duration of BCMA-UCART after injection using FACS or Q-PCR
Measured: Baseline up to 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 Nov 2018
- Study start1 Nov 2019
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Why it stopped: decided by the sponsor
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 0.5-1\*10\~6/KgBW, 1-2\*10\~6/KgBW,2-3\*10\~6/KgBW
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Aibin Liang, PhD, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752541
- Sponsor's protocol ID
- 2018-CAR-00CH3
- Status last verified
- May 2022
- First submitted
- 21 Nov 2018
- Last updated
- 20 May 2022
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of BCMA-UCART（Allogeneic Engineered T-cells Expressing Anti-BCMA Chimeric Antigen Receptor）in the Treatment of Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03752541
- Acronym / sponsor ID
- 2018-CAR-00CH3
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: decided by the sponsor
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Second Xiangya Hospital of Central South University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 26 Nov 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 trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with relapsed or refractory multiple myeloma.
Detailed description
BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW
| Arm | Type | Receives |
|---|---|---|
| BCMA-UCART | Experimental | Biological: BCMA-UCARTEach subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
Key exclusion criteria (9 listed)
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
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-UCARTA conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy. | Biological | BCMA-UCART |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 90 days after T cell infusion
Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
2 secondary outcomes
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 35 days after T cell infusion
Duration of persistence of BCMA-UCART
Time frame: Baseline up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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.
Aibin Liang, PhD principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCMA-UCART in people with Multiple Myeloma, run by Bioray Laboratories 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 11 inclusion and 9 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: paused, as of the sponsor's last update on 20 May 2022. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 90 days after T cell infusion). 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 20 May 2022.