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Engineered immune cells take on Hard-to-Treat blood cancer

NCT ID NCT03758417

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new treatment called LCAR-B38M CAR-T cells in 123 Chinese adults with multiple myeloma that had returned or not responded to at least three prior therapies. The treatment uses a patient's own immune cells, modified in a lab to recognize and attack cancer cells. The main goal was to see how many patients achieved at least a partial response, while also monitoring side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

123 people

The number who actually took part.

Started

Jan 2019

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Measurable disease at Screening * Received at least 3 prior lines of treatment for multiple myeloma a) Undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen * Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) * Participant must have documented evidence of progressive disease based on investigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, participants with documented evidence of PD disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1 Exclusion Criteria: * Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any target * Any therapy that is targeted to B-cell maturation antigen (BCMA) * The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction \[LVEF\] less than \[\<\]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (\<=) 8 weeks of apheresis) * Have received a cumulative dose of corticosteroids equivalent to greater than or equal to(\>=)70 milligram (mg) of prednisone within 7 days prior to apheresis * Diagnosed or treated for invasive malignancy other than multiple myeloma, except: 1. Malignancy treated with curative intent and with no known active disease present for greater than or equal to (\>=) 2 years before enrollment; or 2. Adequately treated non-melanoma skin cancer without evidence of disease * Prior antitumor therapy with insufficient washout period * Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received either of the following: 1. An allogeneic stem cell transplant for multiple myeloma 2. An autologous stem cell transplant less than or equal to (\<=) 12 weeks before apheresis * Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

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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.

Contacts and locations

Locations

  • Fujian Medical University Union hospital

    Fuzhou, Fujian, 350001, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003, China

  • Shanghai Fourth People Hospital

    Shanghai, Shanghai Municipality, 200434, China

  • Sun Yat -Sen University Cancer Center

    Guandong, Guangzhou, 510060, China

  • The First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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