Safety and Efficacy of KSVCBD Injection in B-cell Non-Hodgkin's Lymphoma Expressing CD19 and/or BCMA

NCT07620314 | Recruiting Phase 1

• 1 other identifier: KSVCBD-R101-2
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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) B-cell non-Hodgkin's lymphoma (NHL) CD19 and/or BCMA.

Conditions

Non-Hodgkin's Lymphoma

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 adverse events (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 (10)

• Objective Response Rate (ORR)

  Within 24 months post-infusion

• Duration of Response (DOR)

  Within 24 months post-infusion

• Time to Response (TTR)

  Within 24 months post-infusion

• Progression-Free Survival (PFS)

  Within 24 months post-infusion

• Overall Survival (OS)

  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:
• Histologically or cytologically confirmed B-NHL (according to the 2016 WHO classification of lymphoid neoplasms):
• Diffuse large B-cell lymphoma, not otherwise specified.
• Primary mediastinal large B-cell lymphoma.
• Diffuse large B-cell lymphoma transformed from follicular lymphoma (TFL).
• High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
• Follicular lymphoma (FL).
• High-grade B-cell lymphoma, not otherwise specified.
• Mantle cell lymphoma (pathologically confirmed, with monoclonal B cells carrying t(11.14) and/or overexpressing cyclin D1).
• Marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue \[MALT\] lymphoma).
• Subjects must be in a relapsed or refractory state during the screening period:
• Definition of relapse: Disease progression (PD) after achieving remission (including PR or CR) following at least one standard treatment regimen (must include rituximab).
• Definition of refractory: Must meet any of the following criteria:
• Best response of stable disease (SD) or PD after at least 4 cycles of first-line standard treatment (e.g., 4 cycles of R-CHOP).

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 (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; 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 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)