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

Sponsor
Chinese PLA General Hospital
Study ID
NCT07620275
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Jun 10, 2026
Status verified
May 2026
Primary completion
Dec 15, 2028
Completion
Mar 15, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KSVCBD injection
    Administered by IV infusion

Primary Outcome Measure

Dose limited toxicity (DLT) [ Time Frame: Within 28 days post-infusion ]

Central Contacts

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