Multiple MyelomaPhase 1NCT04537442
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
A 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 single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- IM21 CAR-T cells
- 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
- 3 Sep 2020to 2 Mar 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
- Age ≥60 years old;
- The expected survival time is more than 3 months;
- ECOG score is 0-2;
- Those who voluntarily participate in the study and sign the informed consent;
- Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) >1×10^9/L Total platelet count (PLT)≥35×10^9/L;
- left ventricular ejection fraction > 45%.
Who cannot join
- High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
- Those who have graft versus host disease and need to use immunosuppressive agents;
- Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
- Active hepatitis B or C virus, HIV or other untreated active infected persons;
- Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
- Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing hospital
Beijing, Beijing Municipality, 100730
Hui Liu, MD, PhD, 13520618812, liuhui8140@126.com
About this study
This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.
Read the detailed description
In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.
- 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 cellsDrug
IM21 CAR-T cells
Drug: Fludarabine
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
Drug: Cyclophosphamide
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
Other Names:
Fludarabine Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| IM21 CAR-T cells | Experimental | IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range. Receives: Drug: 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 within 1 month after CAR-T cell infusion
The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion
Measured: 30days
Secondary outcomes (1)
Objective Response Rate(ORR) at 90 days
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start3 Sep 2020 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 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
- Hui Liu, MD, PhD, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537442
- Sponsor's protocol ID
- Immunochina
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang T, Yang Y, Ma L, Feng R, Li J, Zhang C, Bai J, Ding Y, Liu G, Wu F, Lu X, Feng S, Li Z, He T, Li J, Liu H. BCMA-BBZ-OX40 CAR-T Therapy Using an Instant Manufacturing Platform in Multiple Myeloma. J Immunother Cancer. 2024 Sep 23;12(9):e009476. doi: 10.1136/jitc-2024-009476.
PubMed 39313307Wang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022.
PubMed 35651792
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04537442
- Acronym / sponsor ID
- Immunochina
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma
- Phase
- 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
- 3 Sep 2020 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 3 Sep 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 study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.
Detailed description
In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.
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 | Drug: IM21 CAR-T cellsIM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
- Age ≥60 years old;
- The expected survival time is more than 3 months;
- ECOG score is 0-2;
- Those who voluntarily participate in the study and sign the informed consent;
Key exclusion criteria (6 listed)
- High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
- Those who have graft versus host disease and need to use immunosuppressive agents;
- Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
- Active hepatitis B or C virus, HIV or other untreated active infected persons;
- Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
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 Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days Other Names: Fludarabine Cyclophosphamide | Drug | IM21 CAR-T cells |
Primary outcome
Incidence of adverse events within 1 month after CAR-T cell infusion
Time frame: 30days
The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion
1 secondary outcome
Objective Response Rate(ORR) at 90 days
Time frame: 90days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 39313307Wang T, Yang Y, Ma L, Feng R, Li J, Zhang C, Bai J, Ding Y, Liu G, Wu F, Lu X, Feng S, Li Z, He T, Li J, Liu H. BCMA-BBZ-OX40 CAR-T Therapy Using an Instant Manufacturing Platform in Multiple Myeloma. J Immunother Cancer. 2024 Sep 23;12(9):e009476. doi: 10.1136/jitc-2024-009476.
- Derived from this study: PubMed 35651792Wang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022.
- 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.
Hui Liu, MD, PhD principal investigator
Beijing 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 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 7 inclusion and 6 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 3 Sep 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 Fei Wu, MD (+8615801390058, wufei@immunochina.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 within 1 month after CAR-T cell infusion (time frame: 30days). 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 NCT04537442, which also lists 2 linked publications.
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 3 Sep 2020.