Relapsed or Refractory Multiple MyelomaPhase 1NCT03751293
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 Hebei Yanda Ludaopei 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 patient. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2019to 30 Oct 2020
- 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 70 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 18-70 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 who meet at least one of the following conditions:
- Subjects must have received at least two therapy regimens (including proteasome inhibitor or immune-modulator therapy, disease progress or relapse after the last therapy).
- Subjects have received only one therapy regimen, but the investigators judge that patients have unmet treatment needs or can't get benefit from current treatment options.
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- Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1 g/dl(10g/L)
- 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 following 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 CNS metastasis or symptoms of CNS involvement.
- The investigators judge that any increase in the risk of the subject or interference with the results of the trial.
- After allogeneic hematopoietic stem cell transplantation.
- Plasma cell leukemia.
- One week before leukapheresis and one week before CART cell infusion, treated with more than 5mg/d prednisone (or equal amount of other corticosteroids).
- 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 three 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
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, 065200
Peihua Lu, PhD&MD, +86-0316-3306393
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 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, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+ T cells/kg
| 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: The incidence of treatment-emergent adverse events (TEAEs)
The incidence of treatment-emergent adverse events (TEAEs)
Measured: 30 days
Secondary outcomes (4)
Overall response rate (ORR)
Measured: 12 months
Progression free survival (PFS)
Measured: 6 months, 12 months
The CART cell duration in vivo
The copys of BCMA-CART DNA in peripheral blood with qPCR method
Measured: 12 months
The soluble BCMA changes in peripheral blood
The amount of soluble BCMA in peripheral blood with ELISA method
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start8 Jan 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2020 (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.
- 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
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751293
- Sponsor's protocol ID
- 0203-006
- Status last verified
- May 2019
- First submitted
- 15 Nov 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 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
- NCT03751293
- Acronym / sponsor ID
- 0203-006
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 23 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 is a single-center, non-randomized 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 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Volunteered to participate in this study and signed informed consent.
- Age 18-70 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 who meet at least one of the following conditions:
- Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
Key exclusion criteria (19 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 following 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, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+ T cells/kg | Biological | C-CAR088 |
Primary outcome
Safety: The incidence of treatment-emergent adverse events (TEAEs)
Time frame: 30 days
The incidence of treatment-emergent adverse events (TEAEs)
4 secondary outcomes
Overall response rate (ORR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 6 months, 12 months
The CART cell duration in vivo
Time frame: 12 months
The soluble BCMA changes in peripheral blood
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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 Hebei Yanda Ludaopei 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 18 inclusion and 19 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 15 May 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 Peihua Lu, PhD&MD (+86-0316-3306393, peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: The incidence of treatment-emergent adverse events (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 NCT03751293, 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 15 May 2019.