Clinical trial for Multiple Myeloma
Official title Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
ClinicalTrials.gov ID: NCT06503107
What this study is testing
What is Nanobody-based biepitope BCMA-targeting CAR-T cells?
Nanobody-based biepitope BCMA-targeting CAR-T cells is an investigational medicine, given as an infusion into a vein, 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
- To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
- 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 2014).
- Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent...
- Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
You likely can't join if
- Previous diagnosis and treatment of other malignancies within 3 years;
- Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or...
- Patients with active GVHD;
- Patients with a history of severe pulmonary impairment disease;
- Combined with other malignant tumors in the advanced stage;
- Co-infection with severe or persistent infection that cannot be effectively controlled;
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 2014).
- Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms...
- Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
- Have not been treated with antibody-based drugs within 2 weeks prior to cell therapy.
- ECOG score 0-2 points.
- HGB≥70g/L，PLT≥30×10\^9/L.
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) \>30 ml/min；
- Left ventricular ejection fraction (LVEF) ≥50%,
- Baseline peripheral oxygen saturation \> 90%;
- Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
- Previous diagnosis and treatment of other malignancies within 3 years;
- Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary QT prolongation, as judged by the investigator. Echocardiogram...
- Patients with active GVHD;
- Patients with a history of severe pulmonary impairment disease;
- Combined with other malignant tumors in the advanced stage;
- Co-infection with severe or persistent infection that cannot be effectively controlled;
- Combined with severe autoimmune disease or congenital immunodeficiency;
- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA ≥ 500 IU/ml and abnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower limit of detection of the analytical method...
- Human immunodeficiency virus (HIV) infection or syphilis infection;
- Patients with a history of severe allergy to biological products (including antibiotics);
- Patients with central nervous system disorders such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc;
- Pregnant or Lactating Women; Patients and his or her spouses have a fertility plan within 12 months 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.