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

NCT07620275 | Recruiting Phase 1

• 1 other identifier: KSVCBD-R101-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• 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

  Within 28 days post-infusion

• 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.

  Within 24 months post-infusion

• 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

  Within 24 months post-infusion

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  Within 24 months post-infusion

• Minimal Residual Disease (MRD) negativity rate

  Within 24 months post-infusion

• ≥ CR rate

  Within 24 months post-infusion

• Duration of Response (DOR)

  Within 24 months post-infusion

• Time to Response (TTR)

  Within 24 months post-infusion

Study Arms (1)

KSVCBD injection

EXPERIMENTAL

Administered by IV infusion

Biological: KSVCBD injection

Interventions

KSVCBD injection BIOLOGICAL

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

KSVCBD injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (inclusive), any gender.
• Subjects must meet the following diagnostic and treatment criteria:
• 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.
• Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study.
• 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.
• 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.
• Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (3)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

NOT YET RECRUITING

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

Tianjin, China

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weidong Han, M.D.

CONTACT

+86-010-55499341; hanwdrsw@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Biotherapeutic Department

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): March 15, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)