Phase
Condition
Cancer/tumors
Bone Neoplasm
Red Blood Cell Disorders
Treatment
LCAR-B38M CAR-T Cell
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented initial diagnosis of multiple myeloma according to International MyelomaWorking 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, unlessprogressive disease (PD) was documented by IMWG criteria as the best response to theregimen
Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
Participant must have documented evidence of progressive disease based oninvestigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failureto achieve minimal response or development of progressive disease (PD) while ontherapy. Also, participants with documented evidence of PD disease (as above) withinthe previous 6 months and who are refractory or non-responsive to their most recentline of treatment afterwards are eligible
Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
Exclusion
Exclusion Criteria:
Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed atany target
Any therapy that is targeted to B-cell maturation antigen (BCMA)
The following cardiac conditions: a) New York Heart Association (NYHA) stage III orIV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventriculararrhythmia or unexplained syncope, not believed to be vasovagal in nature or due todehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiacfunction (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed byechocardiogram or multiple-gated acquisition (MUGA) scan (performed less than orequal to (<=) 8 weeks of apheresis)
Have received a cumulative dose of corticosteroids equivalent to greater than orequal to(>=)70 milligram (mg) of prednisone within 7 days prior to apheresis
Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
Malignancy treated with curative intent and with no known active diseasepresent for greater than or equal to (>=) 2 years before enrollment; or
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 toGrade 1 or less except for alopecia or peripheral neuropathy
Received either of the following:
An allogeneic stem cell transplant for multiple myeloma
An autologous stem cell transplant less than or equal to (<=) 12 weeks beforeapheresis
- Known active, or prior history of, central nervous system (CNS) involvement orexhibits clinical signs of meningeal involvement of multiple myeloma
Study Design
Connect with a study center
Peking University Third Hospital
Beijing, Beijing 100191
ChinaSite Not Available
Peking University Third Hospital
Beijing 1816670, Beijing Municipality 2038349 100191
ChinaSite Not Available
Fujian Medical University Union hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Fujian Medical University Union hospital
Fuzhou 1810821, Fujian 1811017 350001
ChinaSite Not Available
Sun Yat -Sen University Cancer Center
Guandong, Guangzhou 510060
ChinaSite Not Available
Sun Yat -Sen University Cancer Center
Guandong 9802037, Guangzhou 510060
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing 1799962, Jiangsu 1806260 210029
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing 1799962, Jiangsu 1806260 210008
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai 200025
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai, Shanghai 200003
ChinaSite Not Available
Shanghai Fourth People Hospital
Shanghai, Shanghai 200434
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai 1796236, Shanghai Municipality 1796231 200025
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200003
ChinaSite Not Available
Shanghai Fourth People Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200434
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi 710004
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an 11474004, Shanxi 1795912 710004
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu 1815286, Sichuan 1794299 610041
ChinaSite Not Available
The First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaSite Not Available

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