Safety and Efficacy of KSVCBD Injection in Multiple Myeloma Expressing CD19 and/or BCMA
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years (inclusive), any gender.
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.
Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL, or urinary M-protein level ≥ 200 mg/24 hours. or
Disqualifiers
Expected survival < 3 months.
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.
Solitary extramedullary soft tissue plasmacytoma.
Trial design
Treatments tested in this trial
- KSVCBD injection
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov