Health TrialsbyHealthPanel

JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Genocury Biotech Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: A single-center, open-label, single-arm study of JY232 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment Related adverse events (AEs)

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

Time frame
Up to 2 years after infusion
2

Maximum Tolerated Dose (MTD)

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

Time frame
Up to 28 days after infusion

Secondary outcomes

1

Overall Response Rate (ORR)

Objective Response Rate (ORR) is defined as the proportion of subjects achieving stringent complete remission (sCR), complete remission (CR), very good partial response (VGPR) and partial response (PR).

Time frame
Up to 3 months after infusion
2

Minimal Residual Disease (MRD)

Flow cytometry-based MRD assessment, including the MRD-negative rate and duration of MRD negativity.

Time frame
Up to 3 months after infusion
3

Best Overall Response

The optimal degree of disease status improvement achieved by the patient over the course of the entire clinical trial or treatment period.

Time frame
Up to 3 months after infusion
4

Duration of remission (DOR)

Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of Progressive Disease (PD).

Time frame
Up to 2 years after infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Genocury Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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