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

13 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

9

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Weidong Han, M.D.
  • Número de telefone: +86-010-55499341
  • E-mail: hanwdrsw@sina.com

Locais de estudo

  • China
      • Beijing, China
        • Ainda não está recrutando
        • Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University
        • Contato:
          • Wen Gao, M.D.
      • Tianjin, China
        • Ainda não está recrutando
        • 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
        • Contato:
          • Lugui Qiu, M.D.
        • Subinvestigador:
          • Gang An, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Recrutamento
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Subinvestigador:
          • Yang Liu, M.D.
        • Subinvestigador:
          • Jinhong Shi, M.S.
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Dose limited toxicity (DLT)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
KSVCBD lentiviral particle concentration
Prazo: Within 24 months post-infusion
KSVCBD lentiviral particle concentration in peripheral blood.
Within 24 months post-infusion
Number of CD19-positive cells
Prazo: Within 24 months post-infusion
Number of CD19-positive cells in peripheral blood.
Within 24 months post-infusion
Duration of Response (DOR)
Prazo: 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)
Prazo: Within 24 months post-infusion
Time from administration to first documented PR or better.
Within 24 months post-infusion
Progression-Free Survival (PFS)
Prazo: 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)
Prazo: Within 24 months post-infusion
Time from administration to death from any cause.
Within 24 months post-infusion
Number of CAR-positive T cells
Prazo: Within 24 months post-infusion
Number of CAR-positive T cells in peripheral blood.
Within 24 months post-infusion
CAR gene copy number
Prazo: Within 24 months post-infusion
CAR gene copy number in peripheral blood.
Within 24 months post-infusion
Number of BCMA-positive cells
Prazo: Within 24 months post-infusion
Number of BCMA-positive cells in peripheral blood.
Within 24 months post-infusion
Objective Response Rate (ORR)
Prazo: 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
Prazo: Within 24 months post-infusion
Rate of achieving MRD negativity
Within 24 months post-infusion
≥ CR rate
Prazo: Within 24 months post-infusion
Rate of achieving ≥ CR (CR and sCR)
Within 24 months post-infusion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chinese PLA General Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de setembro de 2026

Conclusão Primária (Estimado)

15 de dezembro de 2028

Conclusão do estudo (Estimado)

15 de março de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de maio de 2026

Primeira postagem (Real)

2 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KSVCBD-R101-1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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