Multiple MyelomaEarly Phase 1NCT07336823
JY232(JY232) Injection in Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing JY232 Injection in people with Multiple Myeloma, run by Shenzhen Genocury Biotech Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- JY232 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must have received at least 2 prior lines of anti-MM therapy (including immunomodulatory drugs, proteasome inhibitors, and anti-Cluster of Differentiation 38 (CD38) therapy, as single agents or in combination. Patients who are intolerant or have contraindications to these therapies are eligible for enrollment if they meet other inclusion/exclusion criteria). Each line of therapy must have included at least one complete cycle, and there must be documented evidence of disease progression on or relapse after the last line of therapy, or permanent discontinuation of therapy due to treatment-related toxicities (the reason for permanent discontinuation due to toxicity must be documented in the CRF). Furthermore, the patient must be refractory or intolerant to any established standard-of-care regimen that, in the investigator's assessment, is of significant clinical benefit to the patient.
- 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.
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- 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);
- Left ventricular ejection fraction (LVEF) ≥ 50 %;
- No clinically significant pericardial effusion detected.
- The subject and their spouse agree to use effective barrier or pharmacological contraception from signing the informed consent until one year after CAR-T cell infusion (excluding the rhythm method).
Who cannot join
- History of graft-versus-host disease (GvHD), or presence of autoimmune disease, immunodeficiency, or any condition requiring long-term immunosuppressive therapy.
- Allogeneic hematopoietic stem cell transplantation within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation within 3 months prior to infusion.
- Prior anti-tumor therapy as follows:
- Monoclonal antibody therapy for multiple myeloma (MM) within 21 days prior to dosing or within at least 5 half-lives (whichever is longer), or
- Cytotoxic chemotherapy within 14 days prior to dosing or within at least 5 half-lives (whichever is longer), or
- Proteasome inhibitor or immunomodulatory agent therapy within 14 days prior to dosing or within at least 5 half-lives (whichever is longer), or
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- Treatment with investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer), or still within the washout period; or treatment involving invasive investigational medical devices, or
- Radiotherapy within 4 weeks prior to dosing, or
- Other anti-tumor therapies not listed above within 14 days prior to dosing or within at least 5 half-lives (whichever is longer).
- Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20mg/day) within 7 days prior to screening, except for physiological replacement, topical, and inhaled steroids.
- Hypertension uncontrolled by two or more antihypertensive medications to the following range (systolic BP <160 mmHg, diastolic BP <90 mmHg); or hypotension below normal range despite treatment (systolic BP <90 mmHg or diastolic BP <60 mmHg).
- Severe cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure New York Heart Association (NYHA) class ≥III, severe arrhythmia.
- Unstable systemic diseases as judged by the investigator: including but not limited to severe hepatic, renal, respiratory, or metabolic diseases requiring medication.
- Diagnosis of malignancy other than MM within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, ductal carcinoma in situ of the breast treated with radical surgery.
- History of solid organ transplantation.
- Presence of central nervous system (CNS) involvement, symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression), or CNS metastasis.
- MM patients with extramedullary disease (except for those with a single para-medullary lesion with a maximum transverse diameter ≤3cm).
- MM patients with concomitant plasma cell leukemia (peripheral blood plasma cell proportion ≥5%).
- Major surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate).
- Treatment with other interventional investigational drugs within 1 month prior to signing the informed consent form (ICF).
- Uncontrolled active infection within 7 days prior to dosing, e.g., positive blood culture ≤72 hours prior to infusion (except for <CTCAE Grade 2 genitourinary tract and upper respiratory tract infections), or infection requiring medication.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable Hepatitis B Virus (HBV) DNA ≥1×10^3 copies/mL in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.
- Pregnant or breastfeeding women.
- Psychiatric illness, impaired consciousness, or central nervous system disorders.
- Non-hematological toxicities from prior therapy have not recovered to baseline or ≤ Grade 1 (per NCI-CTCAE v5.0, except for alopecia and Grade 2 peripheral neuropathy).
- Any other condition considered by the investigator to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Foshan First People's Hospital
Foshan, Guangdong
Yichu Nie, Doctor, +086 0757-83162054, Nieyichu2@126.com
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of JY232 Injection in Patients With Relapsed/Refractory Multiple Myeloma
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.
Read the detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy (JY232 Injection) in patients with relapsed/refractory multiple myeloma. Following screening, eligible subjects will provide informed consent and be enrolled in the study. They will then receive JY232 Injection via intravenous infusion. Subsequently, subjects will undergo safety and efficacy assessments for up to 24 months to evaluate disease control.
- Conditions
- Multiple Myeloma
- Being tested
- JY232 Injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY232 InjectionDrug
Also called in vivo CAR-T
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JY232 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: 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.
Measured: Up to 28 days after infusion
Secondary outcomes (8)
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).
Measured: Up to 3 months after infusion
Minimal Residual Disease (MRD)
Flow cytometry-based MRD assessment, including the MRD-negative rate and duration of MRD negativity.
Measured: Up to 3 months after infusion
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.
Measured: Up to 3 months after infusion
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).
Measured: Up to 2 years after infusion
Time To Progression (TTP)
The duration from the initiation of treatment until the first occurrence of objective disease progression.
Measured: Up to 2 years after infusion
Progression-free survival (PFS)
Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.
Measured: Up to 2 years after infusion
Time to Complete Remission (TTCR)
The time interval from the subject's receipt of JY232 treatment to the first documentation of a complete remission (CR) of the disease.
Measured: Up to 2 years after infusion
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Measured: Up to 2 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Genocury Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ke Huang, Doctor, Study chair, Shenzhen Genocury Biotech Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336823
- Sponsor's protocol ID
- JY-CT-25-009
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of JY232 Injection in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07336823
- Acronym / sponsor ID
- JY-CT-25-009
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shenzhen Genocury Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy (JY232 Injection) in patients with relapsed/refractory multiple myeloma. Following screening, eligible subjects will provide informed consent and be enrolled in the study. They will then receive JY232 Injection via intravenous infusion. Subsequently, subjects will undergo safety and efficacy assessments for up to 24 months to evaluate disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-center, open-label, single-arm study of JY232 Injection | Experimental | Drug: JY232 InjectionThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- Must have received at least 2 prior lines of anti-MM therapy (including immunomodulatory drugs, proteasome inhibitors, and anti-Cluster of Differentiation 38 (CD38) therapy, as single agents or in combination. Patients who are intolerant or have contraindications to these therapies are eligible for enrollment if they meet other inclusion/exclusion criteria). Each line of therapy must have included at least one complete cycle, and there must be documented evidence of disease progression on or relapse after the last line of therapy, or permanent discontinuation of therapy due to treatment-related toxicities (the reason for permanent discontinuation due to toxicity must be documented in the CRF). Furthermore, the patient must be refractory or intolerant to any established standard-of-care regimen that, in the investigator's assessment, is of significant clinical benefit to the patient.
Key exclusion criteria (26 listed)
- History of graft-versus-host disease (GvHD), or presence of autoimmune disease, immunodeficiency, or any condition requiring long-term immunosuppressive therapy.
- Allogeneic hematopoietic stem cell transplantation within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation within 3 months prior to infusion.
- Prior anti-tumor therapy as follows:
- Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20mg/day) within 7 days prior to screening, except for physiological replacement, topical, and inhaled steroids.
- Hypertension uncontrolled by two or more antihypertensive medications to the following range (systolic BP <160 mmHg, diastolic BP <90 mmHg); or hypotension below normal range despite treatment (systolic BP <90 mmHg or diastolic BP <60 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JY232 InjectionAlso: in vivo CAR-TThis 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. | Drug | A single-center, open-label, single-arm study of JY232 Injection |
Primary outcome
Incidence of Treatment Related adverse events (AEs)
Time frame: Up to 2 years after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximum Tolerated Dose (MTD)
Time frame: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicities (DLTs ) observed during the first 28 days of study treatment.
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 3 months after infusion
Minimal Residual Disease (MRD)
Time frame: Up to 3 months after infusion
Best Overall Response
Time frame: Up to 3 months after infusion
Duration of remission (DOR)
Time frame: Up to 2 years after infusion
Time To Progression (TTP)
Time frame: Up to 2 years after infusion
Progression-free survival (PFS)
Time frame: Up to 2 years after infusion
Time to Complete Remission (TTCR)
Time frame: Up to 2 years after infusion
Overall survival (OS)
Time frame: Up to 2 years after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke Huang, Doctor study chair
Shenzhen Genocury Biotech Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JY232 Injection in people with Multiple Myeloma, run by Shenzhen Genocury Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhao, Doctor (+086 0757-83161235, zhaoying@fsyyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related adverse events (AEs) (time frame: Up to 2 years after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.