Multiple MyelomaEarly Phase 1NCT05478343
Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma
A Early Phase 1 study testing IM21 CAR-T cells in people with Multiple Myeloma, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- IM21 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2021to 1 Aug 2023
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor .
- Evidence of cell membrane BCMA expression.
- Subjects must have measurable disease,including 1) Serum M-protein greater or equal to10 g/L. 2) Urine M-protein greater or equal to 200 mg/24 h. 3)Serum free light chain (FLC) assay: involved FLC level greater or equal to 100 mg/L provided serum FLC ratio is abnormal.
- ≥ 18 years of age at the time of signing informed consent.
- Estimated life expectancy >3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
- Adequate organ function.
- Voluntarily sign informed consent form(s).
Who cannot join
- Subjects with graft versus host disease and need to use immunosuppressive agents.
- Subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period.
- Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids)
- Subjects who had previously used any gene therapy product.
- Subjects with known central nervous system disease.
- Subjects with plasmacytic leukemia, Wallenian macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
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- Subjects had the following cardiac conditions, including but not limited to unstable angina pectoris, myocardial infarction or coronary artery bypass graft in the 6 months prior to enrollment, severe arrhythmias with poor drug control;
- Subjects infected with active HBV or HCV, HIV, syphilis or other untreated active infections;
- Pregnant or lactating women.
- Subjects who have other uncontrolled diseases and are considered by the researchers to be unsuitable to participate in the study.
- Any situation that the researcher believes may increase the risk of subjects or interfere with the results of clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of China Medical University
Shenyang, Liaoning
Xiaojing Yan, M.D.
About this study
This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- IM21 CAR-T cells
- 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.
IM21 CAR-T cellsBiological
IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
| Study group | Role | What they receive |
|---|---|---|
| IM21 CAR-T cells | Experimental | Not described Receives: Biological: IM21 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of treatment related AEs
Measured: Up to 28 days after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
Measured: Up to 24 weeks after CAR-T cell infusion
Secondary outcomes (4)
Objective response rate (ORR)
Measured: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
Measured: Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）
Measured: Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)
Measured: Up to 24 weeks after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start6 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (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.
- 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
- Early 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
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojing Yan, M.D., Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478343
- Sponsor's protocol ID
- YMCART201909
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.
PubMed 37192741
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05478343
- Acronym / sponsor ID
- YMCART201909
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 28 Jul 2022 (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 open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM21 CAR-T cells | Experimental | Biological: IM21 CAR-T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor .
- Evidence of cell membrane BCMA expression.
- Subjects must have measurable disease,including 1) Serum M-protein greater or equal to10 g/L. 2) Urine M-protein greater or equal to 200 mg/24 h. 3)Serum free light chain (FLC) assay: involved FLC level greater or equal to 100 mg/L provided serum FLC ratio is abnormal.
- ≥ 18 years of age at the time of signing informed consent.
- Estimated life expectancy >3 months.
Key exclusion criteria (11 listed)
- Subjects with graft versus host disease and need to use immunosuppressive agents.
- Subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period.
- Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids)
- Subjects who had previously used any gene therapy product.
- Subjects with known central nervous system disease.
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 |
|---|---|---|
| IM21 CAR-T cellsIM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range. | Biological | IM21 CAR-T cells |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 28 days after CAR-T cell infusion
Incidence of treatment related AEs
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
Time frame: Up to 24 weeks after CAR-T cell infusion
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
Time frame: Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）
Time frame: Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)
Time frame: Up to 24 weeks after CAR-T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 37192741Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.
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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.
Xiaojing Yan, M.D. principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IM21 CAR-T cells in people with Multiple Myeloma, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 28 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Fei Wu (+8615801390058, wufei@imunopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 28 days after CAR-T cell 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?
On the ClinicalTrials.gov record for NCT05478343, 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 28 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.