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

27. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

9

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Ikke rekrutterer endnu
        • Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University
        • Kontakt:
          • Wen Gao, M.D.
      • Tianjin, Kina
        • Ikke rekrutterer endnu
        • 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
        • Kontakt:
          • Lugui Qiu, M.D.
        • Underforsker:
          • Gang An, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Rekruttering
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Underforsker:
          • Yang Liu, M.D.
        • Underforsker:
          • Jinhong Shi, M.S.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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. Solitary extramedullary soft tissue plasmacytoma.
  5. Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
  6. Presence of CNS metastasis or symptoms of CNS metastasis.
  7. Receipt of anti-tumor therapy that is still within 5 half-lives prior to the planned KSVCBD infusion.
  8. Presence of uncontrolled active infections.
  9. 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.
  10. Known active autoimmune disease requiring systemic treatment.
  11. Known severe allergy to the study drug or any of its components.
  12. Pregnant or breastfeeding women.
  13. Receipt of a live vaccine within 6 weeks prior to enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: KSVCBD injection
Administered by IV infusion
Biologisk: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose limited toxicity (DLT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese PLA General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

15. december 2028

Studieafslutning (Anslået)

15. marts 2029

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSVCBD-R101-1

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med KSVCBD injection

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