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
This trial does not accept healthy volunteersQualifiers
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.
Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
Trial design
Design model
Single group
Treatments tested in this trial
KSVCBD injection
Biological/VaccineKSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: KSVCBD injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion
Time frame
Within 28 days post-infusion2
Incidence and severity of AEs and serious adverse events (SAEs)
AEs refer to any adverse medical events occurring in subjects from the initiation of KSVCBD administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after KSVCBD administration in subjects.
Time frame
Within 24 months post-infusion3
Incidence and severity of adverse events of special interest (AESI)
AESI including grade ≥ 3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections
Time frame
Within 24 months post-infusionSecondary outcomes
1
Objective Response Rate (ORR)
ORR includes Stringent Complete Remission (sCR), CR, Very Good Partial Remission (VGPR), and PR.
Time frame
Within 24 months post-infusion2
Minimal Residual Disease (MRD) negativity rate
Rate of achieving MRD negativity
Time frame
Within 24 months post-infusion3
≥ CR rate
Rate of achieving ≥ CR (CR and sCR)
Time frame
Within 24 months post-infusion4
Duration of Response (DOR)
Time from first documented PR or better to relapse or disease progression, or death from any cause
Time frame
Within 24 months post-infusionSponsors and contacts
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Source ClinicalTrials.gov