Multiple MyelomaPhase 1NCT04727008
CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma
A Phase 1 study testing CXCR4 modified anti-BCMA CAR T cells in people with Multiple Myeloma, run by Sichuan University at 1 site in China.
Trial summary
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CXCR4 modified anti-BCMA CAR T cells
- 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
- 21 Sep 2022to 31 Dec 2025
- 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
- Male or female, 18 to 75 years old.
- The expected survival ≥ 12 week
- ECOG ≤ 2
- Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
- The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
- Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
- Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
- Voluntary informed consent is given, agree to follow the trial treatment and visit plan
Who cannot join
- Patients with other uncontrollable cancer
- Active hepatitis B, hepatitis C, or HIV infection
- Other uncontrolled active disease
- Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
- Patients with uncontrollable hypertension(≥ grade II)
- Patients with history of uncontrollable mental illness
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- Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
- Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
- Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
- Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
- Patients had other conditions that were not appropriate for the study determined by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dan Li, 02885422707, lidan@wchscu.cn
About this study
Official title: Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
- Conditions
- Multiple Myeloma
- Being tested
- CXCR4 modified anti-BCMA CAR T cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4 modified anti-BCMA CAR T cellsBiological
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CXCR4 modified anti-BCMA CAR T cell therapy | Experimental | CAR T cell therapy Receives: Biological: CXCR4 modified anti-BCMA CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLT)
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
Measured: 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: 24 months
Secondary outcomes (2)
ORR (overall response rate)
Proportion of subjects with the best overall response (BOR)
Measured: 3 months，6 months
CRR (complete response rate)
Proportion of subjects with the BOR of sCR+CR at Month 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start21 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 Sichuan 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
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Niu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727008
- Sponsor's protocol ID
- MCART-001
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04727008
- Acronym / sponsor ID
- MCART-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2021 (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.
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXCR4 modified anti-BCMA CAR T cell therapy | Experimental | Biological: CXCR4 modified anti-BCMA CAR T cellsCAR T cell therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 to 75 years old.
- The expected survival ≥ 12 week
- ECOG ≤ 2
- Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
- The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
Key exclusion criteria (11 listed)
- Patients with other uncontrollable cancer
- Active hepatitis B, hepatitis C, or HIV infection
- Other uncontrolled active disease
- Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
- Patients with uncontrollable hypertension(≥ grade II)
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 |
|---|---|---|
| CXCR4 modified anti-BCMA CAR T cellsintravenous infusion | Biological | CXCR4 modified anti-BCMA CAR T cell therapy |
Primary outcome
Dose limiting toxicities (DLT)
Time frame: 2 years
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 24 months
2 secondary outcomes
ORR (overall response rate)
Time frame: 3 months，6 months
CRR (complete response rate)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
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 CXCR4 modified anti-BCMA CAR T cells in people with Multiple Myeloma, run by Sichuan 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 8 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 12 Dec 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 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 DAN LI, Ph.D (+86(028)85423525, lidan@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLT) (time frame: 2 years). 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 12 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.