Multiple MyelomaPhase 1NCT04295018
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
A Phase 1 study testing C-CAR088 in people with Multiple Myeloma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- C-CAR088
- 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
- 23 Oct 2019to Dec 2021
- Phase
- 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
- Age 18-75 years old, male or female;
- The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
- Patients with a clear diagnosis of relapsed or refractory multiple myeloma
- The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1.0 g/dL(10g/L)
- Urine M protein≥200 mg/24h
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- Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
- At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
- ECOG scores 0 - 1;
- Good cardiac and pulmonary organ function;
- Expected survival time > 12 weeks;.
- Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.
Who cannot join
- Have a history of allergy to cellular products;
- Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;
- Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
- Need to use any anticoagulant (except aspirin);
- Patients requiring urgent treatment due to tumor progression or spinal cord compression;
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- Patients with CNS metastasis or symptoms of CNS involvement;
- After allogeneic hematopoietic stem cell transplantation;
- Plasma cell leukemia;
- Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
- Uncontrolled active infection;
- Have used any CAR T cell products or other genetically modified T cell therapy before;
- Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;
- Have a history of alcoholism, drug addiction and mental illness;
- Participated in any other clinical trial within 1 months;
- The investigators believe that there are other circumstances that are not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100010
Daobin Zhou, PhD&MD, 010-69155020, zhoudb@pumch.cn
Lu Zhang, 010-69155660, pumczhanglu@163.com
About this study
Official title: A Phase # Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.
Read the detailed description
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.
- Conditions
- Multiple Myeloma
- Being tested
- C-CAR088
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR088Drug
Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.
| Study group | Role | What they receive |
|---|---|---|
| C-CAR088 | Experimental | Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene Receives: Drug: C-CAR088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088
Measured: 30 days
Secondary outcomes (2)
Overall response rate (ORR)
ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
Measured: 12 months
Progression free survival (PFS)
PFS(based on IMWG 2016 efficacy evaluation criteria)
Measured: 6 months#12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start23 Oct 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (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.
- More trials run by Peking Union Medical College 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
- Investigators
- Daobin Zhou, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295018
- Sponsor's protocol ID
- 0203-007
- Status last verified
- Oct 2019
- First submitted
- 2 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.
PubMed 36100310
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase # Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04295018
- Acronym / sponsor ID
- 0203-007
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Mar 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 is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.
Detailed description
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CAR088 | Experimental | Drug: C-CAR088Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years old, male or female;
- The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
- Patients with a clear diagnosis of relapsed or refractory multiple myeloma
- The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
Key exclusion criteria (16 listed)
- Have a history of allergy to cellular products;
- Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;
- Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
- Need to use any anticoagulant (except aspirin);
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 |
|---|---|---|
| C-CAR088Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell. | Drug | C-CAR088 |
Primary outcome
The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088
Time frame: 30 days
2 secondary outcomes
Overall response rate (ORR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 6 months#12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 36100310Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.
- 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.
Daobin Zhou principal investigator
Peking Union Medical College 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 study testing C-CAR088 in people with Multiple Myeloma, run by Peking Union Medical College 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 13 inclusion and 16 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 4 Mar 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?
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.
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 Daobin Zhou, PhD&MD (010-69155020, zhoudb@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088 (time frame: 30 days). 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 NCT04295018, 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 4 Mar 2020.