Renal Cell Carcinoma (RCC)Phase 1NCT07647744
To Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cancer
A Phase 1 study testing Anti-Human CD70 T-Cell Injection in people with Renal Cell Carcinoma (RCC), run by Hrain Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma, and determine the recommended dose and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Anti-Human CD70 T-Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to Jun 2034
- 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
- Age 18 to 70 years (inclusive), regardless of gender;
- Life expectancy of more than 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
- Subjects with advanced/metastatic renal cell carcinoma (RCC):
- Histologically confirmed clear cell renal cell carcinoma (ccRCC), with an International Metastatic RCC Database Consortium (IMDC) risk stratification of intermediate or high risk as evaluated by the investigator;
- Has at least one measurable lesion according to RECIST 1.1;
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- Tumor tissue samples must test positive for CD70 expression via immunohistochemistry (IHC);
- Must have received at least one prior line of systemic therapy (must include at least: (1) immuno-oncology (IO) combination therapy: concomitant targeting of PD-1 and CTLA-4, or (2) an immune checkpoint inhibitor (PD-1/PD-L1 inhibitor) combined with a VEGF/VEGFR-targeted agent);
- Venous access required for apheresis can be established; hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5×10^9/L, and platelet count ≥ 100× 10^9/L, and the leukepheresis can be carried according to the judgement of investigators;
- Hepatic, renal, cardiac, and pulmonary functions must meet the following criteria:
- Creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula);
- Left ventricular ejection fraction (LVEF) > 50%;
- Baseline peripheral oxygen saturation > 95%;
- Total bilirubin ≤2 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
- Voluntary participation in the clinical study: Must understand and be informed about this study, voluntarily sign the Informed Consent Form (ICF), and be willing to complete all study procedures.
Who cannot join
- Prior treatment with anti-CD70 targeted therapies;
- Brain metastasis from renal cell carcinoma;
- Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;
- Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to enrollment (including fungal, bacterial, viral, or other infections);
- Subjects who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA positive; those who are human immunodeficiency virus (HIV) antibody positive; or those who test positive for syphilis;
- Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to screening, myocardial infarction within 6 months prior to screening, congestive heart failure (New York Heart Association [NYHA] classification ≥ III ), poorly controlled diabetes mellitus (glycated hemoglobin HbA1c > 8% at screening), poorly controlled severe arrhythmia, and hepatic, renal, or metabolic diseases by medication;
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- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion (except for subjects of childbearing potential who are willing to use highly effective and reliable methods of contraception uninterruptedly for 1 year after the study treatment);
- Prior treatment with CAR-T therapy or other genetically modified cell therapies prior to screening;
- History of implantation of a cardiac pacemaker or deep brain stimulator;
- Vaccination with live attenuated vaccines within 4 weeks prior to leukapheresis;
- History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that resulted in end-organ damage, or required systemic immunosuppressive therapy or other systemic disease-controlling medications;
- History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychiatric disorders; or known active CNS involvement or history thereof;
- Subjects who are receiving systemic steroid therapy prior to screening, and who are judged by the investigator to require long-term use of systemic steroids during the study treatment period (excluding inhaled or topical steroids);
- Presence of medical conditions that interfere with the ability to sign the written Informed Consent Form (ICF) or comply with study procedures; or those who are unwilling or unable to comply with study requirements;
- History of severe immediate hypersensitivity reactions to any of the medications to be used in this study;
- Any other conditions that, in the opinion of the investigator, make 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, 1 recruiting
- Recruiting
RenJi Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200000
Wei Xue, M.D., 86-21-68383776, xuewei@renji.com
Wei Zhai, M.D., 86-21-68383776, 19414@renji.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cell Carcinoma
This is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma, and determine the recommended dose and infusion regimen for Phase 2 trials.
Read the detailed description
This study is a single-arm, open-label, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of the investigational agent. It also aims to preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma (RCC) and to determine the appropriate clinical dose and administration regimen for Phase 2.
Subjects who sign the informed consent form (ICF) will undergo screening based on the inclusion/exclusion criteria. Eligible subjects will be sequentially enrolled into treatment cohorts receiving total doses of 2.0 × 10⁸ chimeric antigen receptor-positive (chimeric antigen receptor (CAR)+) T cells, 5.0 × 10⁸ CAR+ T cells, and 1.0 × 10⁹ CAR+ T cells, with each subject receiving a single infusion. The dose-escalation study utilizes a standard "3+3" design, in which 3-6 subjects per cohort will complete a single infusion.
For the first subject enrolled in the initial dose cohort, a safety assessment will be conducted 28 days after the single infusion. If no significant safety concerns are identified, subsequent subjects in the same cohort may receive the infusion, with a total of 3 subjects to be enrolled.
If no dose-limiting toxicity (DLT) occurs among the 3 subjects, the study may escalate to the next dose cohort. If 1 of the 3 subjects in a given cohort experiences a DLT, an additional 3 subjects must be enrolled in the same cohort (for a total of 6 subjects completing DLT evaluation in that cohort): (1) If no DLT occurs among the additional 3 subjects, dose escalation will continue. (2) If 1 of the additional 3 subjects experiences a DLT, dose escalation will stop, and this cohort will be defined as the maximum tolerated dose (MTD). (3) If more than 1 of the additional 3 subjects experiences a DLT, dose escalation will stop. On this basis, if 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD; if only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.
When more than 1 of 3 subjects in a given cohort experience a DLT, dose escalation will stop. On this basis: (1) If 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD. (2) If only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.
If the MTD is not reached at the highest pre-specified dose cohort, the investigators and the sponsor will jointly discuss and decide whether to add further dose cohorts, taking into account preclinical data, clinical safety and tolerability findings, and pharmacokinetic parameters.
During the study, the number of dose cohorts may be increased or decreased, or doses within cohorts may be adjusted, upon joint discussion among the investigators, the sponsor, and the relevant regulatory authorities, based on accumulating PK data and other relevant findings, to ultimately determine the recommended Phase 2 dose (RP2D).
For the selected RP2D cohort, additional subjects may be enrolled if necessary to further characterize the safety profile.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Anti-Human CD70 T-Cell Injection
- Keywords
- Renal cell carcinoma, Chimeric antigen receptor, CD70
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Human CD70 T-Cell InjectionDrug
Autologous genetically modified anti-Human CD70 CAR transduced T cells
| Study group | Role | What they receive |
|---|---|---|
| Anti-Human CD70 T-Cell Injection | Experimental | Not described Receives: Drug: Anti-Human CD70 T-Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
Measured: 28 days post infusion
Secondary outcomes (12)
Number of subjects with adverse event
adverse event is any untoward medical event that occurs in a subject administered an investigational drug
Measured: 2 years post infusion
Change from baseline in perform status as measured by Eastern Cooperative Oncology Group (ECOG) performance status score
Eastern Cooperative Oncology Group (ECOG) performance status score will be assessed by the investigator at each designated time point. The ECOG performance status Score ranges from 0 to 5, where 0 indicates fully active with no restriction, and 5 indicates death. Higher scores indicate worse functional status and greater disease burden.
Measured: 2 years post infusion
Number of participants with clinically significant changes from baseline in laboratory parameters
Laboratory assessments include complete blood count (CBC) with differential (e.g., white blood cell [WBC] count, hemoglobin [Hgb], and platelet count), serum chemistry panel (e.g., serum creatinine [SCr], alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [TBIL]), and coagulation parameters (e.g., prothrombin time [PT] and activated partial thromboplastin time [aPTT]). Clinically significant abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Changes from baseline will be summarized descriptively by visit and toxicity grade.
Measured: 2 years post infusion
Number of participants with clinically significant changes from baseline in physical examination findings
Physical examinations will include assessment of general appearance, vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR], and body temperature), body weight, and organ system review (e.g., cardiovascular, respiratory, abdominal, neurological). Clinically significant changes from baseline will be identified by the investigator and recorded as adverse events (AEs), graded per NCI CTCAE v5.0.
Measured: 2 years post infusion
Pharmacokinetics parameters - Maximum concentration (Cmax)
Maximum chimeric antigen receptor (CAR) level in blood
Measured: 2 years post infusion
Pharmacokinetics parameters - Time to maximum Concentration (Tmax)
Time to peak CAR level in blood
Measured: 2 years post infusion
Pharmacokinetics parameters - Area under the concentration-time curve from 0 to 28 days (AUC0-28)
Area under the CAR level curve in blood from 0 to 28 days
Measured: 2 years post infusion
Pharmacodynamics characteristics- Cytokines concentrations
cytokines level in blood
Measured: 2 years post infusion
Overall response rate (ORR)
Overall response rate (ORR) defined as proportion of subjects who achieved PR or better according to RECIST1.1 as determined by an investigator assessment
Measured: 2 years post infusion
Progression-free survival (PFS)
Progression-free survival (PFS) defined as time from date of initial infusion of CAR-T to date of first disease progression according to RECIST1.1, or death due to any cause, whichever occurs first
Measured: 2 years post infusion
Duration of response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST1.1
Measured: 2 years post infusion
Overall survival (OS)
Overall survival (OS) is measured from the date of the initial infusion of CAR-T to the date of the subject's death
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start30 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hrain Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647744
- Sponsor's protocol ID
- HRAIN01-RCC01-Ⅰ
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety and Tolerability of Anti-Human CD70 T-Cell Injection in Subjects With Advanced/Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07647744
- Acronym / sponsor ID
- HRAIN01-RCC01-Ⅰ
- Conditions
- Renal Cell Carcinoma (RCC)
- Keywords
- Renal cell carcinoma, Chimeric antigen receptor, CD70
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hrain Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 15 Jun 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 is a single-arm, open-label, dose-escalating Phase 1 clinical study. It aims to evaluate the safety, tolerability and pharmacokinetic(PK) profiles of the investigational agent, and preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma, and determine the recommended dose and infusion regimen for Phase 2 trials.
Detailed description
This study is a single-arm, open-label, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of the investigational agent. It also aims to preliminarily assess its efficacy in subjects with advanced/metastatic renal cell carcinoma (RCC) and to determine the appropriate clinical dose and administration regimen for Phase 2.
Subjects who sign the informed consent form (ICF) will undergo screening based on the inclusion/exclusion criteria. Eligible subjects will be sequentially enrolled into treatment cohorts receiving total doses of 2.0 × 10⁸ chimeric antigen receptor-positive (chimeric antigen receptor (CAR)+) T cells, 5.0 × 10⁸ CAR+ T cells, and 1.0 × 10⁹ CAR+ T cells, with each subject receiving a single infusion. The dose-escalation study utilizes a standard "3+3" design, in which 3-6 subjects per cohort will complete a single infusion.
For the first subject enrolled in the initial dose cohort, a safety assessment will be conducted 28 days after the single infusion. If no significant safety concerns are identified, subsequent subjects in the same cohort may receive the infusion, with a total of 3 subjects to be enrolled.
If no dose-limiting toxicity (DLT) occurs among the 3 subjects, the study may escalate to the next dose cohort. If 1 of the 3 subjects in a given cohort experiences a DLT, an additional 3 subjects must be enrolled in the same cohort (for a total of 6 subjects completing DLT evaluation in that cohort): (1) If no DLT occurs among the additional 3 subjects, dose escalation will continue. (2) If 1 of the additional 3 subjects experiences a DLT, dose escalation will stop, and this cohort will be defined as the maximum tolerated dose (MTD). (3) If more than 1 of the additional 3 subjects experiences a DLT, dose escalation will stop. On this basis, if 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD; if only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.
When more than 1 of 3 subjects in a given cohort experience a DLT, dose escalation will stop. On this basis: (1) If 6 subjects had already been enrolled in the preceding dose cohort, the study will be terminated and that cohort will be defined as the MTD. (2) If only 3 subjects were enrolled in the preceding dose cohort, an additional 3 subjects must be enrolled in that cohort for DLT evaluation.
If the MTD is not reached at the highest pre-specified dose cohort, the investigators and the sponsor will jointly discuss and decide whether to add further dose cohorts, taking into account preclinical data, clinical safety and tolerability findings, and pharmacokinetic parameters.
During the study, the number of dose cohorts may be increased or decreased, or doses within cohorts may be adjusted, upon joint discussion among the investigators, the sponsor, and the relevant regulatory authorities, based on accumulating PK data and other relevant findings, to ultimately determine the recommended Phase 2 dose (RP2D).
For the selected RP2D cohort, additional subjects may be enrolled if necessary to further characterize the safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Anti-Human CD70 T-Cell Injection | Experimental | Drug: Anti-Human CD70 T-Cell Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 70 years (inclusive), regardless of gender;
- Life expectancy of more than 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1;
- Subjects with advanced/metastatic renal cell carcinoma (RCC):
- Venous access required for apheresis can be established; hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5×10^9/L, and platelet count ≥ 100× 10^9/L, and the leukepheresis can be carried according to the judgement of investigators;
Key exclusion criteria (16 listed)
- Prior treatment with anti-CD70 targeted therapies;
- Brain metastasis from renal cell carcinoma;
- Concomitant with other uncontrolled malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery;
- Any uncontrolled active infection, including but not limited to active tuberculosis; presence or suspicion of an uncontrolled infection, or an infection requiring systemic intravenous therapy within 14 days prior to enrollment (including fungal, bacterial, viral, or other infections);
- Subjects who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, with peripheral blood HBV DNA titers above the lower limit of detection (LLOD) of the study site; those who are hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA positive; those who are human immunodeficiency virus (HIV) antibody positive; or those who test positive for syphilis;
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 |
|---|---|---|
| Anti-Human CD70 T-Cell InjectionAutologous genetically modified anti-Human CD70 CAR transduced T cells | Drug | Anti-Human CD70 T-Cell Injection |
Primary outcome
Dose limited toxicity (DLT)
Time frame: 28 days post infusion
12 secondary outcomes
Number of subjects with adverse event
Time frame: 2 years post infusion
Change from baseline in perform status as measured by Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: 2 years post infusion
Number of participants with clinically significant changes from baseline in laboratory parameters
Time frame: 2 years post infusion
Number of participants with clinically significant changes from baseline in physical examination findings
Time frame: 2 years post infusion
Pharmacokinetics parameters - Maximum concentration (Cmax)
Time frame: 2 years post infusion
Pharmacokinetics parameters - Time to maximum Concentration (Tmax)
Time frame: 2 years post infusion
Pharmacokinetics parameters - Area under the concentration-time curve from 0 to 28 days (AUC0-28)
Time frame: 2 years post infusion
Pharmacodynamics characteristics- Cytokines concentrations
Time frame: 2 years post infusion
Overall response rate (ORR)
Time frame: 2 years post infusion
Progression-free survival (PFS)
Time frame: 2 years post infusion
Duration of response (DOR)
Time frame: 2 years post infusion
Overall survival (OS)
Time frame: 2 years post 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 2 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 Anti-Human CD70 T-Cell Injection in people with Renal Cell Carcinoma (RCC), run by Hrain Biotechnology 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 16 inclusion and 16 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 2 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 Fang Xiang (86-21-58552006, xiangfang@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: 28 days post infusion). 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 2 Jul 2026.