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Tests treatment safety and results for Multiple Myeloma
Official title A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
ClinicalTrials.gov ID: NCT05998928
What this study is testing
What is Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T Cells?
Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T Cells is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form;
- Aged ≥ 18 years and ≤ 75 years;
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
- The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or...
- Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one...
You likely can't join if
- Previous diagnosis and treatment of other malignancies within 3 years;
- Patients received previous anti-tumor therapies before apheresis including following therapies: targeted therapies, epigenetics modulation drugs...
- Central Nervous System (CNS) involvement;
- Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
- people with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research...
- Patients have a severe allergic history;
See the full eligibility criteria
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form;
- Aged ≥ 18 years and ≤ 75 years;
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
- The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and...
- Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;
- diagnosed as relapsed/refractory disease or primary refractory disease;
- The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;
- Patients must recover from the toxicity of the last therapy (\< grade 2 by CTCAE criteria);
- ECOG score 1-2 points and the expected survival period ≥ 3 months;
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;
- Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min;
- Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days;
- Baseline peripheral oxygen saturation \> 92%;
- Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);
- Left ventricular ejection fraction (LVEF) \> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;
- Without clinically significant pleural effusion;
- Venous access could be established; without contraindications of apheresis.
- Previous diagnosis and treatment of other malignancies within 3 years;
- Patients received previous anti-tumor therapies before apheresis including following therapies: targeted therapies, epigenetics modulation drugs, other drugs or medical devices (invasive) of clinical trials, monoclonal...
- Central Nervous System (CNS) involvement;
- Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
- people with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is...
- Patients have a severe allergic history;
- Patiens have severe systemic diseases or poor cardiovascular, liver, kidney functions;
- Acute or chronic graft versus host disease (GvHD) occurs within 6 months before the screening or needs be treated with immunosuppressive agents;
- Active autoimmune or inflammatory diseases of the nervous system;
- Patients develop oncology emergencies and need to be treated before screening or infusion;
- Uncontrolled infections that need antibiotics treatment;
- Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;
- Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;
- Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;
- Live attenuated vaccine within 4 weeks before screening;
- Patients with severe mental illness;
- Patients are addcited to alcohol or drugs;
- Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- Other conditions considered inappropriate by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.