Engineered immune cells take on Hard-to-Treat blood cancer
NCT ID NCT03758417
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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123 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fujian Medical University Union hospital
Fuzhou, Fujian, 350001, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200025, China
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
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Shanghai Fourth People Hospital
Shanghai, Shanghai Municipality, 200434, China
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Sun Yat -Sen University Cancer Center
Guandong, Guangzhou, 510060, China
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The First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003, China
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The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas