Relapsed or Refractory Multiple MyelomaPhase 1NCT03815383
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 Relapsed or Refractory Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient. 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?
- C-CAR088
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2019to Apr 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
- Volunteered to participate in this study and signed informed consent.
- Age 18-75 years old, male or female.
- Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
- Patients with relapsed or refractory multiple myeloma.
- Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1 g/dl(10g/L)
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- Urine M protein≥200 mg/24h
- Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/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.
- Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- No contraindications of leukapheresis.
- Expected survival > 12 weeks.
- Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.
Who cannot join
- Have a history of allergy to cellular products.
- Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)<80g/L, neutrophils<1000/mm^3, platelets≦50000/mm^3 or platelet count maintained by transfusion.
- Subjects with the clinically significant cardiovascular diseases.
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
- Use any anticoagulant (except aspirin).
- Patients requiring urgent treatment due to tumor progression or spinal cord compression.
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- Patients with active CNS involvement or clinical syndrome of MM meningeal involvement.
- After allogeneic hematopoietic stem cell transplantation.
- Plasma cell leukemia.
- Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
- Uncontrolled active infection.
- Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
- Live vaccine inoculation within four weeks before enrollment.
- 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 one month.
- 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
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Jianyong Li, PhD, lijianyonglm@126.com
About this study
Official title: A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
Read the detailed description
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- C-CAR088
- 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.
C-CAR088Biological
Also called CBM.BCMA Chimeric Antigen Receptor T cell
Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
| Study group | Role | What they receive |
|---|---|---|
| C-CAR088 | Experimental | Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene Receives: Biological: C-CAR088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety:TEAEs
The incidence of treatment-emergent adverse events (TEAEs)
Measured: 30 days
Secondary outcomes (2)
ORR
Overall response rate
Measured: 12 months
PFS
Progression free survival
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 posted24 Jan 2019
- Study start11 Apr 2019
- Primary completionJan 2021 (estimated)
- Study completionApr 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 Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815383
- Sponsor's protocol ID
- 0203-008
- Status last verified
- Dec 2018
- First submitted
- 22 Jan 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03815383
- Acronym / sponsor ID
- 0203-008
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 24 Jan 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.
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
Detailed description
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
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 | Biological: 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 (16 listed)
- Volunteered to participate in this study and signed informed consent.
- Age 18-75 years old, male or female.
- Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
- Patients with relapsed or refractory multiple myeloma.
- Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
Key exclusion criteria (17 listed)
- Have a history of allergy to cellular products.
- Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)<80g/L, neutrophils<1000/mm^3, platelets≦50000/mm^3 or platelet count maintained by transfusion.
- Subjects with the clinically significant cardiovascular diseases.
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
- 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-CAR088Also: CBM.BCMA Chimeric Antigen Receptor T cellAutologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses. | Biological | C-CAR088 |
Primary outcome
Safety:TEAEs
Time frame: 30 days
The incidence of treatment-emergent adverse events (TEAEs)
2 secondary outcomes
ORR
Time frame: 12 months
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 5 Jul 2019.
- 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.
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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 Phase 1 study testing C-CAR088 in people with Relapsed or Refractory Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University 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 16 inclusion and 17 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 5 Jul 2019. 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 Jianyong Li, PhD (025-83718836,83714511, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety:TEAEs (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 NCT03815383, 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 5 Jul 2019.