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New treatment option for Multiple Myeloma
Official title Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
ClinicalTrials.gov ID: NCT05594797
What this study is testing
What is Human BCMA Targeted T Cells Injection?
Human BCMA Targeted T Cells Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as BCMA CAR-T.
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
- A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
- 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
- people must meet all of the following criteria to be enrolled:
- people volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the...
- 18 to 75 years old (including cut-off value)，gender is not limited;
- Expected survival \> 12 weeks;
- Previously diagnosed as multiple myeloma by the International Myeloma Working Group（IMWG） updated criteria;
You likely can't join if
- Any one of the following conditions cannot be selected as a subject：
- people have a history of central nervous system (CNS) diseases such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia...
- people with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis;
- Accompanied by other uncontrolled malignancies, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin...
- Any uncontrollable active infection, including but not limited to active tuberculosis; fungal, bacterial, viral, or other infections that are...
- people with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the...
See the full eligibility criteria
Who can join
- people must meet all of the following criteria to be enrolled:
- people volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
- 18 to 75 years old (including cut-off value)，gender is not limited;
- Expected survival \> 12 weeks;
- Previously diagnosed as multiple myeloma by the International Myeloma Working Group（IMWG） updated criteria;
- One of the following indicators is satisfied:
- Serum M protein ≥ 5 g/L;
- Urine M protein ≥ 200 mg/24h;
- Affected serum free light chain ≥ 100 mg/L and Serum free light chain ratio is abnormal ;
- Patients with relapsed/refractory multiple myeloma, satisfying:
- Patients have received at least 3 prior MM treatment regimens containing at least one proteasome inhibitor and one immunomodulator;
- Progress is documented within 12 months of the most recent antimyeloma treatment, or how well it works assessment does not reach minimal response(MR) or above or progression within 60 days of the most recent antimyeloma...
- ECOG score 0-2;
- Autologous hematopoietic stem cell transplantation is not possible or relapses after autologous hematopoietic stem cell transplantation, but requires further treatment at the investigator's discretion；
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Creatinine clearance rate (estimated by CockcroftGault formula)≥40mL/min;
- Total bilirubin≤2×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN and aspartate aminotransferase (AST)≤2.5×ULN;
- Left ventricular ejection fraction \>50%;
- Baseline peripheral oxygen saturation\>95%;
- The venous access required for collection can be established, no contraindications to leukocyte collection, and leukepheresis can be carried according to the judgement of investigators, satisfying...
What rules you out
- Any one of the following conditions cannot be selected as a subject：
- people have a history of central nervous system (CNS) diseases such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known or history of active central nervous...
- people with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis;
- Accompanied by other uncontrolled malignancies, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma...
- Any uncontrollable active infection, including but not limited to active tuberculosis; fungal, bacterial, viral, or other infections that are uncontrollable or require systemic intravenous therapy are present or...
- people with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site); Hepatitis C...
- Any uncontrolled systemic diseases, including but not limited to unstable angina pectoris, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6...
- people who have a history of pacemaker and brain pacemaker implantation;
- people who have received CAR-T treatment or other genetically modified cell therapies, as well as other BCMA-targeting drugs;
- people with any hematopoietic stem cell transplant performed within the first two months of screening, or any immunosuppressive therapy due to graft-versus-host disease performed during the screening period;
- people who were receiving systemic steroid treatment within 14 days before the screening period and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except...
- people who have received live attenuated vaccine within 4 weeks prior to apheresis;
- In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic...
- Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year after treatment, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; except participants of...
- people who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
- people who have had severe immediate hypersensitivity reactions to any drugs used in this research;
- people who are considered unsuitable to participate in this trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Wenzhou, Zhejiang, 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, Shanghai Municipality, China; Wenzhou, Zhejiang, 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.