phase i clinical study of cbg002 car-t cell in treatment of relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a single arm study to evaluate the efficacy and safety of bcma-targeted car-t cells therapy for patients with relapsed/refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * 18 years old≤ subjects \< 75 years old, all genders; * patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (icf); * according to the diagnostic criteria of the "the guidelines for diagnosis and treatment of multiple myeloma in china (2022)", patients with multiple myeloma are clearly diagnosed; * patients without indications for hematopoietic stem cell transplantation； * meet the definition criteria of relapsed or refractory multiple myeloma. patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; must have a record of disease progression during or within 12 months after the last treatment; * applicable only in the dose expansion phase: the surface bcma positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %; * patient has one or more measurable multiple myeloma lesions； * patients must have appropriate organ function; * patients had no contraindications to peripheral blood mononuclear cell collection; * ecog score 0-2; * expected survival ≥ 12 weeks; * female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating. exclusion criteria: * have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product; * severe cardiovascular and cerebrovascular diseases; * severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study; * have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (asct) within 12 weeks prior to signing the icf; * central nervous system (cns) involvement or symptoms of cns involvement or cns metastases; * stroke or seizure occurred within 6 months prior to signing the icf; * previous plasma cell leukemia; * multiple myeloma with extramedullary lesions; * previous or screening examination showing amyloidosis; * malignant tumor cells with t cell origin revealed by previous pathological examination; * having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy; * within 5 years prior to signing the icf, patients with malignancies other than multiple myeloma; * uncontrolled active infection; * systemic disease judged by the investigator to be unstable; * more than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis; * have used any car-t cell products or other genetically modified t cell therapies; * previously received anti-tumor therapy against bcma targets, including but not limited to antibodies, adcs or car-t; * history of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the icf; * any non-hematologic toxicity due to prior therapy that cannot be restored to grade ≤1 or baseline; * patients with grade ≥2 acute graft-versus-host disease (gvhd) (glucksberg criteria) or extensive chronic gvhd (seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-gvhd treatment during the trial as judged by the investigator; * history of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the icf, which may affect the safety evaluation or compliance as judged by the investigator; * other conditions that are considered inappropriate by the investigator to participate in this study.