KSVCBD injection for multiple myeloma that returned or stopped responding to treatment
Tests KSVCBD, a CAR-T therapy, in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of KSVCBD Injection in Multiple Myeloma Expressing CD19 and/or BCMA
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07620275, who can take part
Where in China
- Biotherapeutic Department of Chinese PLA General HospitalBeijing, ChinaTaking people
- Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjin, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT07620275
- Record updated
- 15 September 2026
- Original description
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM) expressing CD19 and/or BCMA.Read full original descriptionShow less
A Multicenter Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Multiple Myeloma With Positive Expression of CD19 and/or BCMA
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM) expressing CD19 and/or BCMA.
Inclusion: Age 18-75 years (inclusive), any gender; Subjects must meet the following diagnostic and treatment criteria:; 2.1 According to the IMWG 2014 diagnostic criteria, subjects must have a confirmed diagnosis of multiple myeloma and be in a relapsed or refractory state at screening, while meeting all of the following conditions:; Must have received at least 3 prior lines of MM therapy (including a proteasome inhibitor and an immunomodulatory agent). consecutive cycles of induction chemotherapy, hematopoietic stem cell transplantation, and maintenance therapy are considered as one line of therapy if no disease progression occurs between these treatments. each line of therapy must consist of at least one complete treatment cycle, unless the best response to that regimen was disease progression; Must have experienced disease progression during or within 12 months after the most recent anti-myeloma therapy. or the subject must have experienced disease progression within the last 6 months and subsequently shown no response to the most recent line of therapy. Lack of response is defined as failure to achieve at least a minimal response (MR) or experiencing disease progression (PD) during treatment; 2.2 Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study; Presence of measurable lesions at screening as determined by any of the following criteria:; Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL, or urinary M-protein level ≥ 200 mg/24 hours. or; For light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain level ≥ 10 mg/dL and an abnormal serum immunoglobulin κ/λ free light chain ratio; Positive expression of CD19 and/or BCMA in tumor tissue confirmed by flow cytometry and/or histopathology (previous pathology or flow cytometry diagnosis of CD19 and/or BCMA in the patient, as confirmed by the investigator, is acceptable). For subjects who have previously received anti-CD19 and/or anti-BCMA therapy, a tumor biopsy should be performed to confirm current positive expression of CD19 and/or BCMA; Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia); Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion: History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery; Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion; Receipt of anti-tumor therapy that is still within 5 half-lives prior to the planned KSVCBD infusion; Receipt of a live vaccine within 6 weeks prior to enrollment; Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis; Presence of uncontrolled active infections; Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, or positive for hepatitis C virus (HCV) antibody with detectable HCV RNA. except for infections that the investigator judges can be prevented or controlled with medication; Known active autoimmune disease requiring systemic treatment; Known severe allergy to the study drug or any of its components; Expected survival < 3 months; Presence of CNS metastasis or symptoms of CNS metastasis; Pregnant or breastfeeding women.