Multiple MyelomaPhase 2NCT05712083
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
A Phase 2 study testing BCMA CAR-T cells in people with Multiple Myeloma and New Diagnosis Tumor, run by Zhejiang University at 1 site in China.
Trial summary
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma, New Diagnosis Tumor
- What is being tested?
- BCMA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 1 Apr 2024
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.Age and gender unlimited;
- 2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
- 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
- 4.Abnormal plasmocyte BCMA expression positive;
- 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
- 6.The subject has no lung activity infection;
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- 7.Expected life time is more than 3 months;
- 8.ECOG score 0-2 score;
- 9.Voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- 1.Patients with the history of epilepsy or other CNS disease;
- 2.Patients with prolonged QT interval time or severe heart disease;
- 3.Pregnant or breastfeeding;
- 4.Active infection with no cure;
- 5.Patients with active hepatitis B or C infection;
- 6.Previously treated with any genetic therapy;
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- 7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- 9.Those who suffer from other uncontrolled diseases are not suitable to join the study;
- 10.HIV infection;
- 11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, MD, 86-13605714822, hehuangyu@126.com
Mingming Zhang, MD, 13656674208, mingmingzhang@zju.edu.cn
About this study
Official title: Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Read the detailed description
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
- Conditions
- Multiple Myeloma, New Diagnosis Tumor
- Being tested
- BCMA CAR-T cells
- Keywords
- BCMA CAR-T, Multiple Myeloma, New Diagnosis
- 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 CAR-T cellsDrug
Also called BCMA CAR-T cells injection
Each subject receive BCMA CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This is a single arm clinical trial. Receives: Drug: BCMA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary outcomes (4)
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
Measured: At Month 1, 3, 6, 12, 18 and 24
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Measured: Baseline up to 2 years after BCMA CAR T-cells infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Measured: Up to 2 years after BCMA CAR T-cells infusion
Overall survival
Death from any cause from the beginning of cell transfusion
Measured: Up to 2 years after BCMA CAR T-cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start30 Jan 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (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.
- More trials run by Zhejiang 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712083
- Sponsor's protocol ID
- IIT20210024C-R4
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05712083
- Acronym / sponsor ID
- IIT20210024C-R4
- Conditions
- Multiple Myeloma, New Diagnosis Tumor
- Keywords
- BCMA CAR-T, Multiple Myeloma, New Diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 3 Feb 2023 (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.
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Detailed description
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: BCMA CAR-T cellsThis is a single arm clinical trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age and gender unlimited;
- 2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
- 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
- 4.Abnormal plasmocyte BCMA expression positive;
- 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
Key exclusion criteria (11 listed)
- 1.Patients with the history of epilepsy or other CNS disease;
- 2.Patients with prolonged QT interval time or severe heart disease;
- 3.Pregnant or breastfeeding;
- 4.Active infection with no cure;
- 5.Patients with active hepatitis B or C infection;
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 CAR-T cellsAlso: BCMA CAR-T cells injectionEach subject receive BCMA CAR T-cells by intravenous infusion | Drug | Treatment Group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after BCMA CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
4 secondary outcomes
Multiple Myeloma (MM), Overall response rate (ORR)
Time frame: At Month 1, 3, 6, 12, 18 and 24
Complete response rate(CRR)
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Partial response Rate (PRR)
Time frame: Up to 2 years after BCMA CAR T-cells infusion
Overall survival
Time frame: Up to 2 years after BCMA CAR T-cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
He Huang, MD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCMA CAR-T cells in people with Multiple Myeloma and New Diagnosis Tumor, run by Zhejiang 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 9 inclusion and 11 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 21 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 He Huang, MD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after BCMA CAR T-cells infusion). The study lists 2 primary outcomes in all. 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 21 Feb 2023.