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Safety and Efficacy of KSVCBD Injection in Multiple Myeloma Expressing CD19 and/or BCMA

13 de septiembre de 2026 actualizado por: Han weidong, Chinese PLA General Hospital

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

A structurally modified, third-generation, self-inactivating lentiviral vector was used in KSVCBD injection. This modified vector exhibits reduced immunogenicity and enables efficient T-cell targeting, thereby facilitating the in vivo generation of CD19/BCMA CAR T cells from endogenous T cells. Simultaneously targeting BCMA to eliminate plasma cells producing anti-lentivirus and anti-CD19 scFv antibodies enables repeated infusion. The safety and efficacy of CD19/BCMA dual-target autologous CAR-T therapy for the treatment of r/r MM have already been validated in clinical studies. In this study, dose-escalation research will be conducted to explore the safety and preliminary efficacy of CD19/BCMA dual-target in vivo CAR-T therapy in patients with r/r MM who are positive for CD19 and/or BCMA expression.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

9

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Weidong Han, M.D.
  • Número de teléfono: +86-010-55499341
  • Correo electrónico: hanwdrsw@sina.com

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Aún no reclutando
        • Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University
        • Contacto:
          • Wen Gao, M.D.
      • Tianjin, Porcelana
        • Aún no reclutando
        • 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 College
        • Contacto:
          • Lugui Qiu, M.D.
        • Sub-Investigador:
          • Gang An, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100853
        • Reclutamiento
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Sub-Investigador:
          • Yang Liu, M.D.
        • Sub-Investigador:
          • Jinhong Shi, M.S.
        • Contacto:
          • Weidong Han, M.D.
          • Número de teléfono: +86-10-66937463
          • Correo electrónico: hanwdrsw@sina.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Key Inclusion Criteria:

  1. Age 18-75 years (inclusive), any gender.

  2. 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.

  3. 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.
  4. 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.
  5. Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia).
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Key Exclusion Criteria:

  1. Expected survival < 3 months.
  2. 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.
  3. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.
  4. Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
  5. Presence of CNS metastasis or symptoms of CNS metastasis.
  6. Receipt of anti-tumor therapy that is still within 5 half-lives prior to the planned KSVCBD infusion.
  7. Presence of uncontrolled active infections.
  8. 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.
  9. Known active autoimmune disease requiring systemic treatment.
  10. Known severe allergy to the study drug or any of its components.
  11. Pregnant or breastfeeding women.
  12. Receipt of a live vaccine within 6 weeks prior to enrollment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: KSVCBD injection
Administered by IV infusion
Biológico: KSVCBD injection
KSVCBD 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dose limited toxicity (DLT)
Periodo de tiempo: Within 28 days post-infusion
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion
Within 28 days post-infusion
Incidence and severity of adverse events of special interest (AESI)
Periodo de tiempo: Within 24 months post-infusion
AESI including grade ≥ 3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections
Within 24 months post-infusion
Incidence and severity of AEs and serious adverse events (SAEs)
Periodo de tiempo: Within 24 months post-infusion
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.
Within 24 months post-infusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
KSVCBD lentiviral particle concentration
Periodo de tiempo: Within 24 months post-infusion
KSVCBD lentiviral particle concentration in peripheral blood.
Within 24 months post-infusion
Number of CD19-positive cells
Periodo de tiempo: Within 24 months post-infusion
Number of CD19-positive cells in peripheral blood.
Within 24 months post-infusion
Duration of Response (DOR)
Periodo de tiempo: Within 24 months post-infusion
Time from first documented PR or better to relapse or disease progression, or death from any cause
Within 24 months post-infusion
Time to Response (TTR)
Periodo de tiempo: Within 24 months post-infusion
Time from administration to first documented PR or better.
Within 24 months post-infusion
Progression-Free Survival (PFS)
Periodo de tiempo: Within 24 months post-infusion
Time from administration to disease progression or death from any cause, whichever occurs first.
Within 24 months post-infusion
Overall Survival (OS)
Periodo de tiempo: Within 24 months post-infusion
Time from administration to death from any cause.
Within 24 months post-infusion
Number of CAR-positive T cells
Periodo de tiempo: Within 24 months post-infusion
Number of CAR-positive T cells in peripheral blood.
Within 24 months post-infusion
CAR gene copy number
Periodo de tiempo: Within 24 months post-infusion
CAR gene copy number in peripheral blood.
Within 24 months post-infusion
Number of BCMA-positive cells
Periodo de tiempo: Within 24 months post-infusion
Number of BCMA-positive cells in peripheral blood.
Within 24 months post-infusion
Objective Response Rate (ORR)
Periodo de tiempo: Within 24 months post-infusion
ORR includes Stringent Complete Remission (sCR), CR, Very Good Partial Remission (VGPR), and PR.
Within 24 months post-infusion
Minimal Residual Disease (MRD) negativity rate
Periodo de tiempo: Within 24 months post-infusion
Rate of achieving MRD negativity
Within 24 months post-infusion
≥ CR rate
Periodo de tiempo: Within 24 months post-infusion
Rate of achieving ≥ CR (CR and sCR)
Within 24 months post-infusion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chinese PLA General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de septiembre de 2026

Finalización primaria (Estimado)

15 de diciembre de 2028

Finalización del estudio (Estimado)

15 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KSVCBD-R101-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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