Relapse and/or Refractory Multiple MyelomaPhase 1KIV-318NCT07726160
A Study of KIV-318 Injection in Patients With BCMA-Positive Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing KIV-318 in people with Relapse and/or Refractory Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapse and/or Refractory Multiple Myeloma
- What is being tested?
- KIV-318
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 1 Jul 2029
- Phase
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for inclusion only if they meet all of the following criteria:
- Age between 18 and 70 years (inclusive), regardless of gender;
- Diagnosis of multiple myeloma (MM) confirmed per the IMWG diagnostic criteria. and presenting with relapsed/refractory (r/r) MM following at least ≥3 prior lines of therapy. Prior therapies must have included proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and/or CD38 monoclonal antibodies. While prior exposure to all three therapeutic classes is preferred, subjects must have received at least two of these treatment categories (PIs, IMiDs, and/or anti-CD38) during their prior therapy;
- Subjects with r/r MM at screening, with documented disease progression, or who are considered refractory, either during or within 12 months after the most recent anti-myeloma treatment.
- The following cohort-specific criteria must be satisfied:
- For Cohort A: No previous exposure to T-cell engager (TCE) agents and/or CAR-T cell therapy; For Cohort B: Prior treatment with TCEs and/or CAR-T therapy, and positive for BCMA target expression. Prior TCE therapy is defined as completion of at least the full initial step-dose regimen, or cumulative administration of at least 2 therapeutic doses. Prior CAR-T therapy is defined as having received at least one infusion of CAR-T cells targeting any antigen; For Cohort B (additional): In patients whose most recent anti-tumor therapy was a TCE, enrollment will be considered only if the TCE was discontinued due to intolerance or for reasons other than disease progression, with a disease status of stable disease (SD) or better at the time of discontinuation, and with no evidence of rapid disease progression prior to screening.
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- Measurable disease at screening, meeting at least one of the following criteria:
- Serum M-protein level ≥0.5 g/dL; or urine M-protein level ≥200 mg/24h; or for light-chain multiple myeloma in which disease is not measurable in serum or urine: involved serum immunoglobulin free light chain (sFLC) ≥10 mg/dL with an abnormal serum immunoglobulin κ/λ free light chain ratio.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 , and an estimated life expectancy of ≥3 months.
- Bone marrow function test results meeting the following requirements:
- Hemoglobin ≥60 g/L (with no red blood cell transfusion within 1 week prior to screening), and the use of recombinant human erythropoietin is permitted; Absolute neutrophil count (ANC) ≥0.75×10⁹/L (with no granulocyte colony-stimulating factor [G-CSF] use within 1 week prior to screening, or no pegylated G-CSF use within 2 weeks prior to screening); Platelet count (PLT) ≥50×10⁹/L; Absolute lymphocyte count (ALC) ≥0.5×10⁹/L; CD3-positive T-cell absolute count ≥0.15×10⁹/L.
- Adequate organ function, defined as:
- Left ventricular ejection fraction (LVEF) ≥45% assessed by echocardiography, with no clinically significant abnormalities on electrocardiogram (ECG); Creatinine clearance (CrCl) ≥30 mL/min, calculated using the Cockcroft-Gault formula ; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Total bilirubin (TBIL) and alkaline phosphatase (AKP/ALP) ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert's syndrome); Prothrombin time (PT) ≤1.5 × ULN, activated partial thromboplastin time (APTT) <1.5 × ULN, and international normalized ratio (INR) <1.5 × ULN.
- Male subjects with reproductive potential and female subjects of childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent form (ICF) through 1 year after administration of the study drug. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and prior to drug infusion, and must not be lactating.
- Subjects or their legally authorized representatives must agree to participate in this clinical trial and sign the informed consent form (ICF), indicating their understanding of the purpose and procedures of the trial and their willingness to participate in the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from enrollment in this study:
- Receipt of any type of T-cell engager (TCE) therapy within 8 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
- Receipt of any of the following within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug:
- Participation in other interventional clinical trials; Receipt of any anti-tumor chemotherapy, hormonal therapy, targeted therapy, epigenetic therapy, or treatment using invasive investigational medical devices.
- Receipt of proteasome inhibitors, immunomodulatory agents, radiotherapy, or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the investigational drug.
- Presence of meningeal, brainstem, or spinal cord metastasis and/or compression, or active central nervous system (CNS) metastasis.
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- Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to infusion.
- Presence of active second primary malignancies, with the following exceptions: malignancies that have received curative treatment with no known active disease for ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no current evidence of disease.
- Prior treatment with any agent pseudotyped with vesicular stomatitis virus G (VSVG).
- Presence of severe, uncontrolled active infection (bacterial, viral, fungal, etc.) at screening.
- Within 6 months prior to infusion:
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with a detectable peripheral blood HBV DNA titer above the normal range; Positive for hepatitis C virus (HCV) antibody with a detectable peripheral blood HCV RNA titer above the normal range; Positive for human immunodeficiency virus (HIV) antibody; Positive for syphilis screening test.
- Presence of symptomatic heart failure or severe cardiac arrhythmias, including:
- New York Heart Association (NYHA) Class III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF; Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for cases due to vasovagal or dehydration); History of severe non-ischemic cardiomyopathy.
- Clinically significant comorbidities, including:
- Primary immunodeficiency; Stroke or seizure within 6 months prior to screening; Significant clinical evidence of dementia or altered mental status; Parkinson's disease or parkinsonian movement disorder or history thereof.
- Major surgery within 2 weeks prior to study drug administration, or planned major surgery within 2 weeks after study drug administration, excluding surgeries performed under local anesthesia.
- Uncontrolled hypertension, hypercalcemia, or diabetes mellitus.
- Administration of live attenuated vaccines within 1 month prior to study drug administration.
- Known severe hypersensitivity reaction to KIV-318 or its formulation components (e.g., protein components).
- Known severe hypersensitivity reaction to tocilizumab.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China, 300041
Gang An, 13502181109, angang@ihcams.ac.cn
About this study
Official title: A Single-arm, Open-label, Multicenter, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KIV-318 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed/refractory multiple myeloma.
Read the detailed description
This was a single-arm, open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and preliminary antitumor activity of KIV-318 Injection in relapsed/refractory multiple myeloma.
Primary endpoints:
To assess the safety and tolerability of KIV-318 Injection administered via intravenous infusion in patients with relapsed/refractory multiple myeloma, and to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Secondary endpoints:
To evaluate the preliminary efficacy of KIV-318 Injection in relapsed/refractory multiple myeloma; To characterize the pharmacokinetic (PK), pharmacodynamic (PD), and replication-competent lentivirus (RCL) profiles of KIV-318 Injection in humans.
- Being tested
- KIV-318
- Keywords
- BCMA-positive relapsed/refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIV-318Biological
In vivo BCMA-targeted CAR-T KIV-318 Injection
| Study group | Role | What they receive |
|---|---|---|
| In vivo BCMA-targeted CAR-T KIV-318 Injection | Experimental | Not described Receives: Biological: KIV-318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Measured: 28 days of single infusion
Treatment-emergent adverse events (TEAEs)
A Treatment-Emergent Adverse Event (TEAE) is defined as any adverse medical event that occurs from the time of study drug infusion up to Month 24 post-infusion, or within 28 days following premature withdrawal from the study, whichever comes first. TEAEs may present as clinical signs, symptoms, intercurrent illnesses, or abnormal laboratory values, and do not necessarily bear a causal relationship to the study drug. This definition encompasses all new events, as well as any pre-existing conditions that show an increase in severity or frequency relative to baseline, including clinically relevant laboratory test abnormalities.
Measured: 2 years
Secondary outcomes (15)
Minimal residual disease (MRD)
The minimal residual disease (MRD) negativity rate following treatment with KIV-318 injection, defined as the proportion of patients with undetectable tumor cells by high-sensitivity assays after therapy, according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Measured: 2 years
Duration of response (DOR)
Duration of response (DOR) (months) following treatment with KIV-318 injection, defined as the time from the first documented response (including complete response and partial response) to the first occurrence of disease progression or death from any cause.
Measured: 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) (months) following treatment with KIV-318 injection was defined as the time from treatment initiation to the first documented disease progression or death due to any cause.
Measured: 2 years
Overall survival (OS)
Overall survival (OS) (months) was defined as the time from treatment initiation with KIV-318 injection to death due to any cause.
Measured: 2 years
Replication competent lentivirus (RCL)
Detection of replication competent lentivirus (RCL) (copies/μg gDNA) in peripheral blood by Q-PCR following infusion of KIV-318 injection.
Measured: 2 years
Maximum concentration (Cmax) of CAR transgene copy number
Maximum concentration (Cmax) of CAR transgene copy number (copies/μg gDNA) in peripheral blood following infusion of KIV-318 Injection
Measured: 2 years
Time (day) to maximum concentration (Tmax) of CAR transgene copy number
Time (day) to maximum concentration (Tmax) of CAR transgene copy number in peripheral blood following infusion of KIV-318 Injection
Measured: 2 years
AUC₀-₂₈d of CAR transgene copy number
Area under the concentration-time curve from time zero to Day 28 (AUC₀-₂₈d) of CAR transgene copy number ( copies/μg gDNA) in peripheral blood following infusion of KIV-318 Injection
Measured: 28 days
Maximum concentration (Cmax) of CAR-positive T cells
Maximum concentration (Cmax) of CAR-positive T cells (cells/μL or ×10⁹/L) in peripheral blood following infusion of KIV-318 Injection
Measured: 2 years
Time (day) to maximum concentration (Tmax) of CAR-positive T cells
Time (day) to maximum concentration (Tmax) of CAR-positive T cells in peripheral blood following infusion of KIV-318 Injection
Measured: 2 years
AUC₀-₂₈d of peripheral blood CAR-positive T cells
AUC₀-₂₈d of peripheral blood CAR-positive T cells (cells/μL or ×10⁹/L) post KIV-318 Injection infusion
Measured: 28 days
Cytokine levels
Peripheral blood samples will be collected following administration of KIV-318 to assess cytokine levels (pg/mL ) (e.g., IL-6, IL-10, IFN-γ, and TNF-α)
Measured: 3 months
C-reactive protein (CRP) and ferritin
Peripheral blood samples will be collected following administration of KIV-318 to assess levels of C-reactive protein (CRP) (mg/dl) and ferritin (ng/mL).
Measured: 3 months
Immunoglobulin levels
Peripheral blood samples will be collected following administration of KIV-318 to assess immunoglobulin levels (g/L) (IgG, IgA, and IgM)
Measured: 2 years
Lymphocyte subsets
Peripheral blood samples will be collected following administration of KIV-318 to evaluate levels of peripheral lymphocyte subsets (including percentage (%) and/or absolute counts of T cells, B cells, and NK cells(×10⁹/L))
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726160
- Sponsor's protocol ID
- IIT2026052
- Acronym
- KIV-318
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KIV-318 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT07726160
- Acronym / sponsor ID
- KIV-318 / IIT2026052
- Keywords
- BCMA-positive relapsed/refractory multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 24 Jul 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.
A single-arm, open-label, multicenter, dose-escalation clinical trial to evaluate the safety, tolerability, and preliminary efficacy of KIV-318 Injection in patients with relapsed/refractory multiple myeloma.
Detailed description
This was a single-arm, open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and preliminary antitumor activity of KIV-318 Injection in relapsed/refractory multiple myeloma.
Primary endpoints:
To assess the safety and tolerability of KIV-318 Injection administered via intravenous infusion in patients with relapsed/refractory multiple myeloma, and to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Secondary endpoints:
To evaluate the preliminary efficacy of KIV-318 Injection in relapsed/refractory multiple myeloma; To characterize the pharmacokinetic (PK), pharmacodynamic (PD), and replication-competent lentivirus (RCL) profiles of KIV-318 Injection in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vivo BCMA-targeted CAR-T KIV-318 Injection | Experimental | Biological: KIV-318 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects are eligible for inclusion only if they meet all of the following criteria:
- For Cohort A: No previous exposure to T-cell engager (TCE) agents and/or CAR-T cell therapy; For Cohort B: Prior treatment with TCEs and/or CAR-T therapy, and positive for BCMA target expression. Prior TCE therapy is defined as completion of at least the full initial step-dose regimen, or cumulative administration of at least 2 therapeutic doses. Prior CAR-T therapy is defined as having received at least one infusion of CAR-T cells targeting any antigen; For Cohort B (additional): In patients whose most recent anti-tumor therapy was a TCE, enrollment will be considered only if the TCE was discontinued due to intolerance or for reasons other than disease progression, with a disease status of stable disease (SD) or better at the time of discontinuation, and with no evidence of rapid disease progression prior to screening.
- Serum M-protein level ≥0.5 g/dL; or urine M-protein level ≥200 mg/24h; or for light-chain multiple myeloma in which disease is not measurable in serum or urine: involved serum immunoglobulin free light chain (sFLC) ≥10 mg/dL with an abnormal serum immunoglobulin κ/λ free light chain ratio.
- Hemoglobin ≥60 g/L (with no red blood cell transfusion within 1 week prior to screening), and the use of recombinant human erythropoietin is permitted; Absolute neutrophil count (ANC) ≥0.75×10⁹/L (with no granulocyte colony-stimulating factor [G-CSF] use within 1 week prior to screening, or no pegylated G-CSF use within 2 weeks prior to screening); Platelet count (PLT) ≥50×10⁹/L; Absolute lymphocyte count (ALC) ≥0.5×10⁹/L; CD3-positive T-cell absolute count ≥0.15×10⁹/L.
- Left ventricular ejection fraction (LVEF) ≥45% assessed by echocardiography, with no clinically significant abnormalities on electrocardiogram (ECG); Creatinine clearance (CrCl) ≥30 mL/min, calculated using the Cockcroft-Gault formula ; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Total bilirubin (TBIL) and alkaline phosphatase (AKP/ALP) ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert's syndrome); Prothrombin time (PT) ≤1.5 × ULN, activated partial thromboplastin time (APTT) <1.5 × ULN, and international normalized ratio (INR) <1.5 × ULN.
Key exclusion criteria (22 listed)
- Subjects meeting any of the following criteria will be excluded from enrollment in this study:
- Participation in other interventional clinical trials; Receipt of any anti-tumor chemotherapy, hormonal therapy, targeted therapy, epigenetic therapy, or treatment using invasive investigational medical devices.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with a detectable peripheral blood HBV DNA titer above the normal range; Positive for hepatitis C virus (HCV) antibody with a detectable peripheral blood HCV RNA titer above the normal range; Positive for human immunodeficiency virus (HIV) antibody; Positive for syphilis screening test.
- New York Heart Association (NYHA) Class III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF; Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for cases due to vasovagal or dehydration); History of severe non-ischemic cardiomyopathy.
- Primary immunodeficiency; Stroke or seizure within 6 months prior to screening; Significant clinical evidence of dementia or altered mental status; Parkinson's disease or parkinsonian movement disorder or history thereof.
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 |
|---|---|---|
| KIV-318In vivo BCMA-targeted CAR-T KIV-318 Injection | Biological | In vivo BCMA-targeted CAR-T KIV-318 Injection |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 28 days of single infusion
Dose limiting toxicity (DLT) in the dose escalation phase
Treatment-emergent adverse events (TEAEs)
Time frame: 2 years
A Treatment-Emergent Adverse Event (TEAE) is defined as any adverse medical event that occurs from the time of study drug infusion up to Month 24 post-infusion, or within 28 days following premature withdrawal from the study, whichever comes first. TEAEs may present as clinical signs, symptoms, intercurrent illnesses, or abnormal laboratory values, and do not necessarily bear a causal relationship to the study drug. This definition encompasses all new events, as well as any pre-existing conditions that show an increase in severity or frequency relative to baseline, including clinically relevant laboratory test abnormalities.
15 secondary outcomes
Minimal residual disease (MRD)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Replication competent lentivirus (RCL)
Time frame: 2 years
Maximum concentration (Cmax) of CAR transgene copy number
Time frame: 2 years
Time (day) to maximum concentration (Tmax) of CAR transgene copy number
Time frame: 2 years
AUC₀-₂₈d of CAR transgene copy number
Time frame: 28 days
Maximum concentration (Cmax) of CAR-positive T cells
Time frame: 2 years
Time (day) to maximum concentration (Tmax) of CAR-positive T cells
Time frame: 2 years
AUC₀-₂₈d of peripheral blood CAR-positive T cells
Time frame: 28 days
Cytokine levels
Time frame: 3 months
C-reactive protein (CRP) and ferritin
Time frame: 3 months
Immunoglobulin levels
Time frame: 2 years
Lymphocyte subsets
Time frame: 2 years
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 24 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KIV-318 in people with Relapse and/or Refractory Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China 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 15 inclusion and 22 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: opening soon, as of the sponsor's last update on 24 Jul 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Gang An (13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 28 days of single 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 24 Jul 2026.