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Multiple MyelomaPhase 1/2NCT07169500

Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients

A Phase 1/2 study testing CAR-T in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Myeloma
What is being tested?
CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
3 Mar 2025to 2 Mar 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects voluntarily participate in the study and sign the informed consent form (ICF) themselves or through their legal guardian;
  • Confirmed diagnosis of multiple myeloma through flow cytometry or immunohistochemistry;
  • Subjects must have adequate organ function and meet all of the following test results:
  • Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥ 40 ml/min
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  • Prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) < 1.5 × ULN, international normalized ratio (INR) < 1.5 × ULN
  • Hemoglobin (Hb) ≥ 60 g/L
  • Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L (no granulocyte colony-stimulating factor [G-CSF] or other growth factors received within 7 days prior to screening laboratory tests)
  • Absolute lymphocyte count (ALC) ≥ 0.5 × 10^9/L
  • Platelets (PLT) ≥ 50 × 10^9/L (no platelet transfusion received within 7 days prior to screening laboratory tests)
  • Left ventricular ejection fraction (LVEF) ≥ 45%
  • Blood oxygen saturation (SpO2) ≥ 92%
  • ECOG score of 0-1, see Appendix 5 for ECOG scoring;
  • Expected survival ≥ 3 months;
  • Female participants of childbearing potential must have a negative pregnancy test and not be breastfeeding; female or male participants of childbearing potential must use effective contraceptive methods or devices for 24 months after cell infusion.

Who cannot join

  • History of allergy to any component of the cellular product;
  • Severe heart disease, including but not limited to:
  • Myocardial infarction, coronary angioplasty, or stent implantation within 6 months prior to signing the ICF
  • Unstable angina
  • Severe arrhythmia
  • History of severe non-ischemic cardiomyopathy
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  • Congestive heart failure (New York Heart Association [NYHA] class III or IV), NYHA scores are in Appendix 2
  • Stroke or seizure within 6 months prior to signing the ICF;
  • Autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy;
  • Malignant tumors other than multiple myeloma within 3 years prior to signing the ICF, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, and other in situ cancers at other sites one year after radical surgery, provided there is no ongoing treatment and no signs of recurrence during the screening period;
  • Presence of uncontrolled active infection;
  • Unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medication.
  • Within one week before lymphocyte collection, the storage device falls under any of the following conditions:
  • Peripheral blood hepatitis B virus (HBV) DNA test value is above the detection limit
  • Hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive
  • Human immunodeficiency virus (HIV) antibody positive
  • Syphilis antigen or antibody positive
  • CMV-DNA positive
  • Within one week before lymphocyte collection, use of more than 5 mg/day of prednisone (or an equivalent dose of other corticosteroids);
  • Prior use of any CAR-T cell products or other genetically modified T cell therapies;
  • Prior BCMA-targeted therapy;
  • Vaccination with a live vaccine within 4 weeks before signing the ICF;
  • History of alcoholism, drug abuse, or psychiatric disorders; Other conditions that the investigator deems unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Xu, MD contact

13920593907

xuyan1@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

    Yan Xu, MD, 13920593907 ext. +86, xuyan1@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients

Read the detailed description

This study is a single-center, open-label, prospective investigator-initiated clinical study. Patients are assigned to treatment groups in a non-randomized manner based on their condition and disease status, and are divided into transplant and non-transplant groups according to whether ASCT is combined. The study analyzes and compares the safety and efficacy of BCMA-CART ± ASCT treatment in young MM patients.

Being tested
CAR-T
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR-TBiological

    Chimeric antigen receptor T cells (car-t) are genetically engineered MHC independent tumor specific killer cells.

Study groups in NCT07169500
Study groupRoleWhat they receive
BCMA-CARTExperimentalAll study participants are non-randomly assigned based on their disease status before the start of treatment. Those suitable for transplantation enter the transplantation (ASCT CART) treatment group, while those not suitable for transplantation enter the non-transplant treatment group. Participants in the transplant group will undergo ASCT at an appropriate time before receiving BCMA-CART treatment. Participants in the non-transplant group do not need to undergo ASCT and can proceed directly to BCMA-CART treatment at an appropriate time.
Receives: Biological: CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment and comparison of MRD negativity rate 3 months after BCMA-CART±ASCT

    MRD by flow cytometry

    Measured: 3 month

Secondary outcomes (7)

  1. Progression-free Survival (PFS)

    Time from CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first

    Measured: 2 years after CAR-T infusion

  2. Minimal Residual Disease (MRD) negetive rate

    Proportion of subjects who achieved MRD negative

    Measured: at day28, M2, M3, M6, M9, M12, M15, M18, M24 after CAR-T infusion

  3. Overall response rate (ORR) evaluated by the investigators

    Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators

    Measured: 2 years after CAR-T infusion

  4. Duration of Response (DOR)

    Time from first response evaluated by an investigators to disease progression or death from any cause

    Measured: 2 years after CAR-T infusion

  5. Time to Response (TTR)

    Time from CAR-T infusion to first documentation of response evaluated by an investigator

    Measured: 2 years after CAR-T infusion

  6. Overall Survival (OS)

    Time from CAR-T infusion to time of death due to any cause

    Measured: 2 years after CAR-T infusion

  7. PK:Cmax,Tmax,AUC(0-28days),Tlast

    flow cytometry and qPCR

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start3 Mar 2025
  3. Primary completion2 Mar 2028 (estimated)
  4. Study completion2 Mar 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a single-center, open-label, prospective investigator-initiated clinical trial. Patients are assigned to treatment groups non-randomly based on their condition and disease status, and are divided into a transplant group and a non-transplant group depending on whether they undergo ASCT. The study aims to analyze and compare the safety and efficacy of BCMA-CART ± ASCT treatment in young MM patients. Each group plans to enroll 25 subjects, with a total of 50 subjects expected to be enrolled in this study. After treatment, subjects will be followed up for safety and efficacy until the completion of the study or withdrawal from the study (withdrawal reasons include disease progression, loss to follow-up, withdrawal of informed consent, adverse events, initiation of new anti-tumor treatment, death, etc.), with the first occurrence taking precedence.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169500
Sponsor's protocol ID
IIT2025025
Status last verified
Feb 2026
First submitted
31 Jul 2025
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China 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 16 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Xu, MD (13920593907, xuyan1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment and comparison of MRD negativity rate 3 months after BCMA-CART±ASCT (time frame: 3 month). 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 NCT07169500.

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 2 Mar 2026.

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