JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma

NCT07336823 | Recruiting Early Phase 1

• 1 other identifier: JY-CT-25-009
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory multiple myeloma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY232 injection in the treatment of relapsed/refractory multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Related adverse events (AEs)

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Up to 2 years after infusion

• Maximum Tolerated Dose (MTD)

  MTD will be determined based on Dose-Limiting Toxicities (DLTs ) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

Secondary Outcomes (8)

• Overall Response Rate (ORR)

  Up to 3 months after infusion

• Minimal Residual Disease (MRD)

  Up to 3 months after infusion

• Best Overall Response

  Up to 3 months after infusion

• Duration of remission (DOR)

  Up to 2 years after infusion

• Time To Progression (TTP)

  Up to 2 years after infusion

Study Arms (1)

A single-center, open-label, single-arm study of JY232 Injection

EXPERIMENTAL

This is a single-center, open-label, single-arm study to evaluate the efficacy and safety of intravenous JY232 Injection in patients with relapsed/refractory multiple myeloma. JY232 is designed to generate functional CAR-T cells directly within the body.

Drug: JY232 Injection

Interventions

JY232 Injection DRUG

This open-label, single-arm study is designed to evaluate the efficacy and safety of an in vivo Chimeric Antigen Receptor T-cell (CAR-T) therapy (JY232 preparation) in patients with relapsed or refractory multiple myeloma. Enrolled subjects will receive a single intravenous infusion of JY232, followed by a mandatory one-month in-hospital observation period for initial safety and efficacy assessments. Subsequently, subjects will enter a follow-up phase lasting up to 2 years to monitor long-term disease control.

Also known as: in vivo CAR-T

A single-center, open-label, single-arm study of JY232 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:

• The subject voluntarily signs the informed consent form, is willing and able to comply with all study requirements.
• Age 18-75 years, male or female.
• Diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
• Must have undergone stem cell transplantation (SCT) or be transplant-ineligible.

You may not qualify if:

• The subject's tumor sample (bone marrow) tests positive for B-Cell Maturation Antigen (BCMA) expression on the plasma cell membrane via immunohistochemistry (IHC) or flow cytometry.
• Presence of measurable disease at screening determined by any one of the following criteria:
• Proportion of clonal plasma cells in bone marrow cytology, bone marrow biopsy histology, or flow cytometry ≥ 5%;
• Serum monoclonal protein (M-protein) level: Immunoglobulin G (IgG) type M-protein ≥10 g/L; or Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE), Immunoglobulin M (IgM) type M-protein ≥5 g/L;
• Urine M-protein level ≥200 mg/24 hours;
• For MM without measurable serum or urine M-protein: involved serum free light chain ≥100 mg/L (10 mg/dL) and abnormal serum κ/λ free light chain ratio (\<0.26 or \>1.65);
• Or clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Confirmed increase in Sum of the Product of Diameters (SPD) of existing plasmacytomas or bone lesions (≥50% increase in SPD of measurable lesions, absolute increase ≥1 cm).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 (see Appendix 1 for ECOG scale).
• Expected survival time ≥12 weeks.
• The subject must have adequate organ function, meeting all the following laboratory results prior to enrollment:
• Hematology: Absolute neutrophil count (ANC) ≥ 1×10\^9 /L (growth factor support is allowed, but must not have been administered within 7 days prior to the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10\^9 /L; Platelets ≥50×10\^9 /L (must not have received transfusion support within 7 days prior to the laboratory test); Hemoglobin ≥60 g/L (no red blood cell (RBC) transfusion within 7 days prior to the laboratory test; recombinant human erythropoietin is allowed);
• Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN); Serum total bilirubin ≤1.5 × ULN;
• Renal function: If available, measured CrCl from 24-hour urine collection; otherwise, calculated creatinine clearance (CrCl) via Cockcroft-Gault formula ≥ 40 ml/min;
• Coagulation: Fibrinogen ≥1.0 g/L; Activated partial thromboplastin time (aPTT) ≤1.5 × ULN; Prothrombin time (PT) ≤1.5 × ULN;
• Oxygen saturation \>91% (on room air);

Sponsors & Collaborators

• Shenzhen Genocury Biotech Co., Ltd.: lead

Study Sites (1)

Foshan First People's Hospital

Foshan, Guangdong, China

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

Study Officials

• Ke Huang, Doctor

  Shenzhen Genocury Biotech Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Ying Zhao, Doctor

CONTACT

+086 0757-83161235; zhaoying@fsyyy.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 13, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)