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New treatment option for Relapsed
Official title A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06732232
What this study is testing
What is CD19/CD20/BCMA CAR-T?
CD19/CD20/BCMA CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed.
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 arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.
- Phase 1: an early, usually small safety study
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
- Participants must meet all of the following criteria in order to be enrolled:
- Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations/procedures;
- Age range: 18-75 years old;
- Expected survival period is not less than 12 weeks;
- ECOG score ≤ 2 points;
You likely can't join if
- Any of the following situations cannot be selected as a subject:
- Asymptomatic (smoking type) multiple myeloma;
- Multiple myeloma with only extramedullary lesions present;
- Plasma cell leukemia;
- Merge amyloidosis;
- Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression;
See the full eligibility criteria
- Participants must meet all of the following criteria in order to be enrolled:
- Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations/procedures;
- Age range: 18-75 years old;
- Expected survival period is not less than 12 weeks;
- ECOG score ≤ 2 points;
- The bone marrow flow cytometry results showed positive BCMA antigen (including weak positive, moderate positive, and strong positive);
- According to the IMWG criteria, a diagnosis of multiple myeloma with measurable lesions must meet at least one of the following criteria:
- Serum M protein (SPEP) ≥ 5g/L
- 24-hour urinary M-protein excretion rate ≥ 0.2g (200mg)
- Serum free light chain (sFLC) ≥ 100 mg/L and abnormal free light chain ratio
- The ratio of primitive plasma cells to immature plasma cells in bone marrow cytology examination is greater than 5%, or the flow cytometry detection of monoclonal plasma cells is greater than 5%
- Those who have received treatment with at least three different mechanisms of action (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed, and have experienced...
- There is no significant abnormality in lung function, and the oxygen saturation is greater than 92% in the absence of oxygen inhalation;
- The blood biochemistry test results meet the following criteria:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- 24-hour serum creatinine clearance rate ≥ 30 mL/min
- Lipase and amylase ≤ 2 × ULN
- The blood routine test meets the following criteria:
- Lymphocyte count\>0.5 × 10 \^ 9/L
- Neutrophil count ≥ 1.0 × 10 \^ 9/L
- Hemoglobin ≥ 60g/L
- Platelets ≥ 40 × 10 \^ 9/L
- Men with fertility and women of childbearing age must agree to use effective contraceptive measures from the signing of the informed consent form until 2 years after the use of the study drug. Women of childbearing age...
- Any of the following situations cannot be selected as a subject:
- Asymptomatic (smoking type) multiple myeloma;
- Multiple myeloma with only extramedullary lesions present;
- Plasma cell leukemia;
- Merge amyloidosis;
- Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression;
- Pregnancy or lactation period;
- Individuals who are HBsAg positive or HBcAb positive, unless HBV-DNA is less than 100 IU/ml or below the minimum detectable value; Individuals who are positive for hepatitis C virus (HCV) antibodies and HCV-RNA...
- Cardiovascular diseases with clinical significance, including any of the following:
- QT interval (QTcF) after heart rate correction:\>470 milliseconds;
- New York Heart Association Grade II and above heart failure;
- Left ventricular ejection fraction (LVEF) ≤ 50%;
- Poorly controlled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 95 mm Hg)
- Arrhythmias that have clinical significance or require antiarrhythmic treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion tachycardia, and complete left bundle branch block);
- Has experienced unstable angina or acute myocardial infarction within the 6 months prior to signing the ICF;
- Previously received any anti-CD45 or anti-CD3 treatment;
- Individuals who are allergic to any of the components of the drugs used in this study, including but not limited to Qing Lin drugs (cyclophosphamide, fludarabine), etc;
- Received any investigational drug or systemic anti-tumor treatment within 4 weeks (or 5 half lives of the drug, whichever the researcher deems more appropriate) prior to single collection;
- History of other primary malignant tumors within 5 years prior to treatment, except for the following situations:
- Fully treat cured cervical carcinoma in situ;
- Localized basal cell carcinoma or squamous cell carcinoma of the skin;
- Any uncontrolled active infection within 4 weeks prior to single collection requires parenteral antibiotics, antiviral or antifungal treatment;
- Individuals with a history of active pulmonary tuberculosis infection within one year prior to single sampling (excluding people with a history of active pulmonary tuberculosis infection more than one year ago who...
- Accompanying or having a history of interstitial lung disease or interstitial pneumonia;
- people who receive autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of signing the ICF, or who plan to undergo ASCT during the study period;
- people who have received allogeneic stem cell therapy in the past; The researchers believe that complications or other conditions in the people may affect their compliance with the protocol or make them unsuitable to...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 Shanghai, 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.