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Could a One-Two punch of CAR-T and stem cell transplant beat myeloma early?

NCT ID NCT07169500

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new treatment for young adults (18-55) newly diagnosed with multiple myeloma. It uses a patient's own immune cells, engineered to attack the cancer (BCMA-CART), either alone or combined with a stem cell transplant. The goal is to see if this approach can wipe out the cancer more deeply and keep it away longer. The trial is currently recruiting 50 participants to evaluate safety and early effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCMA-targeted CAR-T cells (a type of immune cell therapy) with or without stem cell transplant
What this could lead to
If successful, this could offer a more effective way to control multiple myeloma early on, potentially leading to longer remission periods for young patients.
What could go wrong
This is an early-phase trial with only 50 participants, so results may not apply broadly. CAR-T therapy can cause serious side effects like cytokine release syndrome, and the long-term benefits are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Young female, 18-55 years old; 1. Subjects voluntarily participate in the study and sign the informed consent form (ICF) themselves or through their legal guardian; 2. Confirmed diagnosis of multiple myeloma through flow cytometry or immunohistochemistry; 3. 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 * 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% 4. ECOG score of 0-1, see Appendix 5 for ECOG scoring; 5. Expected survival ≥ 3 months; 6. 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. Exclusion Criteria: 1. History of allergy to any component of the cellular product; 2. 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 * Congestive heart failure (New York Heart Association \[NYHA\] class III or IV), NYHA scores are in Appendix 2 3. Stroke or seizure within 6 months prior to signing the ICF; 4. Autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy; 5. 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; 6. Presence of uncontrolled active infection; 7. Unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medication. 8. 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 9. Within one week before lymphocyte collection, use of more than 5 mg/day of prednisone (or an equivalent dose of other corticosteroids); 10. Prior use of any CAR-T cell products or other genetically modified T cell therapies; 11. Prior BCMA-targeted therapy; 12. Vaccination with a live vaccine within 4 weeks before signing the ICF; 13. History of alcoholism, drug abuse, or psychiatric disorders; Other conditions that the investigator deems unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Hematology & Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

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