Advanced Malignant TumorsEarly Phase 1NCT07409766
A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors
A Early Phase 1 study testing CAR-M in people with Advanced Malignant Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-arm, open-label, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- CAR-M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 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
- Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, with no gender restriction.
- Histologically or cytologically confirmed advanced solid tumor (partial laboratory test results are acceptable):
- HER2-positive: IHC 3+ or IHC 2+ with ISH+ PSMA+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10% FAP+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10%
- Disease status:
- Subjects (HER2-targeted): Patients with advanced solid tumor who are refractory to or intolerant of DS-8201 treatment.
- Subjects (PSMA-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.
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- Subjects (FAP-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy of at least 3 months (as assessed by the investigator).
- Adequate organ function, defined as follows:
- Hematologic: Hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 80 × 10⁹/L Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver metastases) Renal: Serum creatinine ≤ 1 × ULN, or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula) Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% (assessed by ECHO or MUGA) Pancreatic: Serum amylase / lipase ≤ 1.5 × ULN
- Electrolytes: Corrected calcium, potassium, and magnesium levels within the normal range.
- Subjects must have at least one measurable lesion as defined by RECIST Version 1.1.
- Adequate venous access for apheresis with no contraindications.
- Tolerability to G-CSF: No history of severe hypersensitivity to filgrastim or its biosimilars.
- Subjects must fully understand the purpose, nature, methods, and potential adverse reactions of the study, and voluntarily participate in the study and sign the informed consent form prior to initiation of any study procedures.
Who cannot join
- Known hypersensitivity to CAR-M or any of its excipients.
- History of severe hypersensitivity to filgrastim (G-CSF) or tocilizumab.
- Known history of substance abuse.
- A history of ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-related myocarditis following prior immunotherapy.
- Active infection requiring systemic therapy, except for the following conditions: uncomplicated urinary tract infection (UTI) (afebrile and resolved after 3 days of antibiotic therapy) or bacterial pharyngitis (confirmed by GAS testing and treated with appropriate antibiotics).
- HIV infection, active hepatitis B virus (HBV) infection (HBV DNA > upper limit of normal [ULN]), or active hepatitis C virus (HCV) infection (HCV RNA > ULN).
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- History of malignant neoplasm other than the following within the past 5 years:
- Curable malignant neoplasms (e.g., basal cell carcinoma, carcinoma in situ of the cervix/breast, or cutaneous squamous cell carcinoma).
- Malignant neoplasms with a favorable prognosis (e.g., papillary thyroid carcinoma, carcinoma in situ of the skin or breast), regardless of whether they have been cured or not.
- Receipt of other investigational drugs or therapies within 4 weeks prior to the first administration of CAR-M, or ongoing participation in the safety follow-up period of other investigational drugs or therapies.
- Presence of severe, non-healing wounds, ulcers, or fractures within 4 weeks prior to the first administration of CAR-M.
- History of substance abuse or psychiatric disorders.
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Acute events: myocardial infarction, stroke, or New York Heart Association (NYHA) Class III-IV heart failure within 6 months.
- Thromboembolism: symptomatic deep vein thrombosis or pulmonary embolism (DVT/PE) within 6 months (unless on stable anticoagulant therapy).
- Arrhythmia: ventricular arrhythmia requiring intervention or Grade II-III atrioventricular block.
- Confirmed pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, or severe pulmonary dysfunction.
- For patients with prior treatment: ≥ Grade 2 hematological toxicity or ≥ Grade 3 non-hematological toxicity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, except for toxicities deemed to pose no safety risk by the investigator (e.g., alopecia, Grade 2 peripheral neuropathy).
- Indwelling catheters/drainage tubes (excluding central venous catheters).
- Central nervous system (CNS) disorders: epilepsy, stroke, dementia, or autoimmune diseases involving the CNS.
- Active or untreated brain or CNS disorders, including brain metastases that have not stabilized for ≥ 8 weeks after radiotherapy, symptomatic brain metastases, or cytologically confirmed carcinomatous meningitis.
- Severe immunodeficiency.
- History of prior transplantation: allogeneic stem cell transplantation or solid organ transplantation.
- Active autoimmune disease requiring systemic immunosuppression (prednisone dose > 10 mg/day or equivalent).
- History of high-risk autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], inflammatory bowel disease [IBD]). Exceptions: stable vitiligo/psoriasis, hormone-replaced hypothyroidism, or well-controlled Type 1 diabetes mellitus (HbA1c ≤ 7%).
- Use of systemic glucocorticoids (prednisone > 10 mg/day) or other immunosuppressants within 14 days (exceptions: topical/inhaled steroids, adrenal replacement therapy).
- Receipt of major organ surgery, severe trauma, or invasive dental procedures (e.g., tooth extraction, dental implantation) within 4 weeks prior to the first administration of CAR-M, or planned elective surgery during the study period.
- Active autoimmune disease or history of recurrent autoimmune disease (excluding well-controlled Type 1 diabetes mellitus; hypothyroidism manageable with hormone replacement therapy alone; or dermatological conditions not requiring systemic therapy, e.g., vitiligo or psoriasis).
- Presence of active infection requiring systemic anti-infective therapy.
- Positive pregnancy test in women of childbearing potential (WOCBP).
- Refusal to use effective contraceptive measures from the time of informed consent until 1 year after treatment.
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
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100000
LI-NING, 010-87788713
About this study
This is a single-arm, open-label, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting various antigens (including HER2, PSMA, FAP, etc.) in patients with advanced solid tumors. The clinical trial is designed to be conducted in cohorts, with patients enrolled into respective cohorts based on target antigen and indication screening
Read the detailed description
This study adopts a single-arm, open-label, single-center, dose-escalation platform clinical trial design, which is constructed based on an adenovirus vector delivery system. The primary objective of this trial is to systematically evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary anti-tumor activity of the investigational CAR-M (chimeric antigen receptor-macrophage) injection in patients with advanced solid tumors. The investigational product targets multiple specific antigens, including but not limited to HER2 (human epidermal growth factor receptor 2), PSMA (prostate-specific membrane antigen), and FAP (fibroblast activation protein).
The trial is designed to be implemented in a cohort-based manner, with strict enrollment criteria and screening procedures to ensure the rationality and scientificity of cohort grouping. Specifically, all potential participants will first undergo comprehensive screening, which mainly includes two core aspects: target antigen detection and indication confirmation. For target antigen detection, qualified detection techniques will be used to verify the expression level of the target antigen in the patient's tumor tissue or related samples, ensuring that the patient's tumor expresses the corresponding target antigen targeted by the CAR-M injection in the cohort. For indication confirmation, the patient's clinical diagnosis, tumor stage, previous treatment history, and other relevant clinical data will be reviewed in detail to confirm that the patient meets the advanced solid tumor indication requirements corresponding to the cohort.
Only patients who pass both target antigen screening and indication screening will be enrolled into the corresponding cohort according to the matching relationship between the target antigen they express and the indication. Each cohort will focus on evaluating the investigational CAR-M injection targeting a specific antigen in patients with corresponding advanced solid tumors, and the dose-escalation process will be carried out step by step in accordance with pre-set trial protocols, so as to gradually clarify the safe dose range, pharmacokinetic characteristics, and preliminary anti-tumor effect of the product in different populations.
- Conditions
- Advanced Malignant Tumors
- Being tested
- CAR-M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-MBiological
IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Split-dose administration | Experimental | Total dose: 5.0×10⁹ cells Day 1: 50% of the total dose Day 7: The remaining 50% of the dose [only if no ≥Grade 2 chronic kidney syndrome/nephrotoxicity is observed after the first dose] Receives: Biological: CAR-M |
| Cohort 2: Bolus administration | Experimental | Total dose: 5.0×10⁹ cells Day 1: Full dose Receives: Biological: CAR-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion.
Measured: Within 28 days after the first infusion
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Measured: From signing ICF until 24 months after the last infusion.
Determine and characterize the optimal dosing regimen (full dose vs. split dose).
Split dose is superior for CAR-M optimal dosing: it mitigates acute toxicities (e.g., cytokine responses) via gradual immune activation, sustains robust CAR-M cell expansion and in vivo persistence, and improves safety in high-risk patients. Full dose enables rapid therapeutic efficacy in low-risk cohorts with intact organ function. Optimal regimens are tailored to patient baseline status/indications, validated via dose-escalation trials for balance of safety and anti-tumor activity.
Measured: Day 0, Day 7, Day 14
Secondary outcomes (8)
To obtain the pharmacokinetic (PK) characteristics of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Quantitative Assessment of CAR Transgene Copy Number in Peripheral Blood Cells
Measured: Day 0, Day 7, Day 14, Day 21, Day 28
Serum Cytokines of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, and IL-17 will be measured as systemic pharmacodynamic (PD) biomarkers and potential predictors of cytokine release syndrome (CRS).
Measured: 0 hours, 6 hours, 24 hours, and 72 hours after each infusion.
Tumor Microenvironment (TME) Infiltration
Tumor biopsies will be collected to evaluate CAR-M infiltration within the tumor microenvironment.
Measured: 24 hours post-infusion, Day 7 (peak activity), Day 28, and Day 90
Dynamic Monitoring of Target Expression
Dynamic changes in HER2, PSMA, and FAP expression (IHC H-score variation) will be analyzed as pharmacodynamic (PD) biomarkers, while baseline target expression status will be used as an eligibility criterion.
Measured: Screening Phase, Day 28, Day 90
ORR (Objective Response Rate)
The proportion of participants who achieve a complete response (CR) or partial response (PR) as their best overall response, as assessed according to RECIST v1.1.
Measured: Day 28、Month 3、Month 6、Month 9、Month 12
DOR (Duration of Response)
The time from the first documented evidence of complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurs first.
Measured: Day 28、Month 3、Month 6、Month 9、Month 12
DCR (Disease Control Rate)
The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to RECIST v1.1.
Measured: Day 28、Month 3、Month 6、Month 9、Month 12
PFS (Progression-Free Survival)
he time from treatment initiation (or randomization, if applicable) to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Day 28、Month 3、Month 6、Month 9、Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start31 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 Advanced Malignant TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- CAR-M
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Dr, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409766
- Sponsor's protocol ID
- NCC5975
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 Feb 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07409766
- Acronym / sponsor ID
- NCC5975
- Conditions
- Advanced Malignant Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Feb 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, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting various antigens (including HER2, PSMA, FAP, etc.) in patients with advanced solid tumors. The clinical trial is designed to be conducted in cohorts, with patients enrolled into respective cohorts based on target antigen and indication screening
Detailed description
This study adopts a single-arm, open-label, single-center, dose-escalation platform clinical trial design, which is constructed based on an adenovirus vector delivery system. The primary objective of this trial is to systematically evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary anti-tumor activity of the investigational CAR-M (chimeric antigen receptor-macrophage) injection in patients with advanced solid tumors. The investigational product targets multiple specific antigens, including but not limited to HER2 (human epidermal growth factor receptor 2), PSMA (prostate-specific membrane antigen), and FAP (fibroblast activation protein).
The trial is designed to be implemented in a cohort-based manner, with strict enrollment criteria and screening procedures to ensure the rationality and scientificity of cohort grouping. Specifically, all potential participants will first undergo comprehensive screening, which mainly includes two core aspects: target antigen detection and indication confirmation. For target antigen detection, qualified detection techniques will be used to verify the expression level of the target antigen in the patient's tumor tissue or related samples, ensuring that the patient's tumor expresses the corresponding target antigen targeted by the CAR-M injection in the cohort. For indication confirmation, the patient's clinical diagnosis, tumor stage, previous treatment history, and other relevant clinical data will be reviewed in detail to confirm that the patient meets the advanced solid tumor indication requirements corresponding to the cohort.
Only patients who pass both target antigen screening and indication screening will be enrolled into the corresponding cohort according to the matching relationship between the target antigen they express and the indication. Each cohort will focus on evaluating the investigational CAR-M injection targeting a specific antigen in patients with corresponding advanced solid tumors, and the dose-escalation process will be carried out step by step in accordance with pre-set trial protocols, so as to gradually clarify the safe dose range, pharmacokinetic characteristics, and preliminary anti-tumor effect of the product in different populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CAR-M
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Split-dose administration | Experimental | Biological: CAR-MTotal dose: 5.0×10⁹ cells Day 1: 50% of the total dose Day 7: The remaining 50% of the dose [only if no ≥Grade 2 chronic kidney syndrome/nephrotoxicity is observed after the first dose] |
| Cohort 2: Bolus administration | Experimental | Biological: CAR-MTotal dose: 5.0×10⁹ cells Day 1: Full dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, with no gender restriction.
- Histologically or cytologically confirmed advanced solid tumor (partial laboratory test results are acceptable):
- HER2-positive: IHC 3+ or IHC 2+ with ISH+ PSMA+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10% FAP+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10%
- Subjects (HER2-targeted): Patients with advanced solid tumor who are refractory to or intolerant of DS-8201 treatment.
- Subjects (PSMA-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.
Key exclusion criteria (31 listed)
- Known hypersensitivity to CAR-M or any of its excipients.
- History of severe hypersensitivity to filgrastim (G-CSF) or tocilizumab.
- Known history of substance abuse.
- A history of ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-related myocarditis following prior immunotherapy.
- Active infection requiring systemic therapy, except for the following conditions: uncomplicated urinary tract infection (UTI) (afebrile and resolved after 3 days of antibiotic therapy) or bacterial pharyngitis (confirmed by GAS testing and treated with appropriate antibiotics).
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 |
|---|---|---|
| CAR-MIV | Biological | Cohort 1: Split-dose administration, Cohort 2: Bolus administration |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Within 28 days after the first infusion
Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion.
Incidence of Adverse Events (AEs)
Time frame: From signing ICF until 24 months after the last infusion.
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Determine and characterize the optimal dosing regimen (full dose vs. split dose).
Time frame: Day 0, Day 7, Day 14
Split dose is superior for CAR-M optimal dosing: it mitigates acute toxicities (e.g., cytokine responses) via gradual immune activation, sustains robust CAR-M cell expansion and in vivo persistence, and improves safety in high-risk patients. Full dose enables rapid therapeutic efficacy in low-risk cohorts with intact organ function. Optimal regimens are tailored to patient baseline status/indications, validated via dose-escalation trials for balance of safety and anti-tumor activity.
8 secondary outcomes
To obtain the pharmacokinetic (PK) characteristics of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28
Serum Cytokines of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Time frame: 0 hours, 6 hours, 24 hours, and 72 hours after each infusion.
Tumor Microenvironment (TME) Infiltration
Time frame: 24 hours post-infusion, Day 7 (peak activity), Day 28, and Day 90
Dynamic Monitoring of Target Expression
Time frame: Screening Phase, Day 28, Day 90
ORR (Objective Response Rate)
Time frame: Day 28、Month 3、Month 6、Month 9、Month 12
DOR (Duration of Response)
Time frame: Day 28、Month 3、Month 6、Month 9、Month 12
DCR (Disease Control Rate)
Time frame: Day 28、Month 3、Month 6、Month 9、Month 12
PFS (Progression-Free Survival)
Time frame: Day 28、Month 3、Month 6、Month 9、Month 12
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 Feb 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.
Ning Li, Dr principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 CAR-M in people with Advanced Malignant Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 31 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 13 Feb 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 Ning Li (8613581809307, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Within 28 days after the first infusion). The study lists 3 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 Feb 2026.