Status:
NOT_YET_RECRUITING
BCMA/GPRC5D CAR-T Therapy for Multiple Myeloma
Lead Sponsor:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Multiple Myeloma Refractory
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief Summary
This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion.
Detailed Description
This study is a single-arm, mult-center clinical trial of dose escalation and dose expansion, primarily aimed at evaluating the safety, tolerability, and preliminary efficacy of BCMA/GPRC5D CAR-T cell...
Eligibility Criteria
Inclusion
- The patient or their guardian understands and voluntarily signs the informed consent form and expects to complete the follow-up examinations and treatments of the research protocol；
- Age 18-85 years old (inclusive), gender unrestricted;
- In accordance with the standards for the recurrence of multiple myeloma in the 'Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022)';
- Determine the presence of measurable lesions during screening based on any of the following criteria: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL or urine M protein level ≥ 200 mg/24 hours; or diagnosed with light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
- Has previously received at least first-line or higher treatment for multiple myeloma.
- Patients with lymphoma must have at least one measurable lesion from baseline according to the revised IWG criteria for assessing the efficacy of malignant lymphoma；
- The organ functions well；
- ECOG performance status score 0-3 and estimated survival time greater than 3 months.
Exclusion
- Diagnosed with or treated for other invasive malignant tumors, excluding multiple myeloma, within 3 years;
- Previous anti-tumor treatments (before the collection and preparation of CAR-T blood): received targeted therapy, epigenetic therapy, or experimental drug treatment within 14 days or within at least 5 half-lives (whichever is shorter), or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulator treatment within 7 days; received radiotherapy within 14 days (except when the irradiated field covers ≤5% of the bone marrow reserve);
- During screening, individuals with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis;
- Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
- Those with a history of anaphylaxis \[A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest\] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
- Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.
- Screen for patients who have had acute/chronic graft-versus-host disease (GVHD) within the past 6 months, or who require immunosuppressive treatment for GVHD;
- Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.
- Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.
- Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.
- Persons with severe mental illness.
- Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .
- Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.
- hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.
- Immunosuppressive agents: those who were receiving immunosuppressive agents within 2 weeks before PBMC collection.
- Vaccination with live (attenuated) virus vaccine within 4 weeks prior to screening.
- Alcoholics or those with a history of substance abuse.
- Patients who, in the investigator's judgment and/or clinical criteria, have contraindications to any study procedure or other medical conditions that may put them at unacceptable risk.
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07196124
Start Date
October 10 2025
End Date
December 9 2028
Last Update
September 29 2025
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