Solid TumorPhase 1/2NCT06939270
CD73/AXL Targeted HypoSti.CAR-T Cells in CD73/AXL Positive Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing CD73/AXL.HypoSti.CAR-T cells, Albumin-Bound Paclitaxel and Cyclophosphamide in people with Solid Tumor, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CD73/AXL.HypoSti.CAR-T cells, Albumin-Bound Paclitaxel and Cyclophosphamide
- 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
- 1 May 2025to 1 May 2028
- Phase
- Phase 1/2
- 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
- Age 18-75 (inclusive).
- The Eastern Cooperative Oncology Group (ECOG) score ≤2 and Estimated life expectancy of more than 3 months.
- Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no National Comprehensive Cancer Network (NCCN) guideline recommended standard firstline therapy. Tumor types include but are not limited to:biliary malignancies, pancreatic cancer, lung cancer, breast cancer, head and neck malignancies, gynecological tumors, etc.
- The expression of CD73 or AXL antigen is≥50%.
- At least one measurable lesion at baseline per RECIST version 1.1.
- Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study.
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- Adequate organ function as defined by the following criteria:
- Absolute neutrophil count (ANC) ≥ 1 x 10^9/L, Platelet count ≥75 x 10^9/ L, hemoglobin (Hgb) ≥ 90g/L ;
- Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min;
- Serum aspartate amino transferase (AST) and alanine aminotransferase (ALT), ≤3.0 x ULN (≤5 x ULN for patients with liver cancer or metastases); Total serum bilirubin ≤1.5 x ULN(≤3 x ULN for patients with liver cancer or metastases);
- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings;
- International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN;
- Baseline oxygen saturation >91% on room air.
- Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to <= grade 1 toxicity (except for hematological toxicities and clinically non-significant toxicities such as alopecia).
- Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
- Ability to understand and sign a written informed consent document.
Who cannot join
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- Received cytotoxic chemicals, monoclonal antibodies, immunotherapy, targeted therapy or other anti-tumor therapy within 4 weeks or 5 half-lives before enrollment.
- Pregnant, lactating, or breastfeeding females.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of allergy or intolerance to study drug components.
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
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- Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- Known brain metastases or active central nervous system (CNS).Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
- Previous or concurrent cancer within 5 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors.
- Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- Active bleeding or known hemorrhagic tendency.
- Vaccination within 30 days of study enrollment.
- Being participating any other trials or withdraw within 4 weeks.
- Researchers believe that other reasons are not suitable for clinical trials.
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
Biotherapeutic Department, Chinese PLA General Hospital
Beijing, Beijing Municipality
Weidong Han, Ph.D, 010-66937231, hanwdrsw@sina.com
Yang Liu, M.D, 010-66939460, liuyang301blood@163.com
About this study
Official title: Phase I/II Clinical Trial of CD73/AXL Targeted HypoSti.CAR-T Cells in Treating Patients With CD73/AXL Positive Advanced/Metastatic Solid Tumors
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses Of CD73/AXL.HypoSti.CAR-T cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Read the detailed description
Currently, CAR T-cell therapy still faces significant challenges in its application to solid tumors due to multiple obstacles, including the lack of tumor-specific antigens, the complex immunosuppressive tumor microenvironment (TME), tumor heterogeneity, and on targeted/non-targeted (OTOT) toxicity. Previous studies have found that intratumoral hypoxic microenvironment facilitated the development and metastasis of tumor cells. Meanwhile, cytotoxic T cells, including CAR-T cells, struggle to survive and proliferate in this low-oxygen microenvironment.
CD73 (also known as 5'-nucleotidase) and AXL (a receptor tyrosine kinase) are both overexpressed in multiple solid tumors, but less so in normal tissues. They are both involved in regulating tumorigenesis, development, metastasis processes, correlating with inferior prognosis.Dual targeting of CD73 and AXL can effectively address antigen escape and tumor heterogeneity, representing a promising novel immunotherapy strategy.
In this study, combining hypoxia-activated precision with dual-targeting synergy,Investigators have developed a novel CD73/AXL.HypoSti.CAR-T that could effectively expand and survive in hypoxic TME ,offering enhanced efficacy and safety for solid tumors in animal models. Further clinical development is warranted to validate these promising preclinical results. So we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD73/AXL.HypoSti.CAR-T cell in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD73/AXL.HypoSti.CAR-T cell therapy (1 × 10^6 cells/ kg, 3 × 10^6 cells/kg, 1 × 10^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell infusion at RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities (DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD73/AXL.HypoSti.CAR-T cell therapy.
- Conditions
- Solid Tumor
- Being tested
- CD73/AXL.HypoSti.CAR-T cells, Albumin-Bound Paclitaxel, Cyclophosphamide, Fludarabine
- Keywords
- CD73/AXL, hypoxia, CAR-T Cells
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD73/AXL.HypoSti.CAR-T cellsBiological
Dose escalation: Dose1 (1×10^6 cells/kg) , Dose 2(3×10^6 cells/kg) ,Dose 3 (1×10^7cells/kg); Dose expansion: RP2D.
Albumin-Bound PaclitaxelDrug
Also called Albumin-bound paclitaxel for Injection
Administered intravenously at dose of 100-200mg/m2 on day -5 .
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Administered intravenously at a total dose of 15-30mg/kg on day -3 and day -2 .
FludarabineDrug
Also called Cyclophosphamide for Injection
Administered intravenously at dose of 30mg/m2/d on day -3 and day -2.
| Study group | Role | What they receive |
|---|---|---|
| CD73/AXL.HypoSti.CAR-T cells | Experimental | Enrolled participants will be given a preconditioning regimen consisted of albumin-bound paclitaxel, cyclophosphamide and fludarabine before the infusion of CD73/AXL.HypoSti.CAR-T cells.
Enrolled patients in this arm will be administered CD73/AXL.HypoSti.CAR-T cells in "3+3" based escalation manner. Receives: Biological: CD73/AXL.HypoSti.CAR-T cells; Drug: Albumin-Bound Paclitaxel; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of treatment related adverse events (TRAEs).
TRAEs are defined as any medical events since the initiation of CD73/AXL.HypoSti.CAR-T cell therapy . Cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be evaluated according to the standards released by American Society for Transplantation and Cellular Therapy (ASTCT) criteria in 2019, and the others will be graded by common terminology criteria for adverse events (CTCAE) V5.0.
Measured: Up to 12 months
Phase 1:Incidence of dose limiting toxicities (DLTs).
DLTs are defined as CD73/AXL.HypoSti.CAR-T cell therapy related adverse events within the first 28 days that meet the following criteria:
- Grade 4 CRS or grade 3 CRS that is not resolved to grade 2 or lower within 2 weeks;
- Grade 3 ICANS lasting for ≥7 days or Grade 4 ICANS;
- Any other Grade ≥4 and Grade 3 AEs related to the CD73/AXL.HypoSti.CAR-T infusion that lasts for ≥14 days, except hematology toxicity.
Measured: Up to 28 days after infusion.
Phase 1: RP2D
The recommended dose for phase 2 was determined through phase 1 study.
Measured: Up to 12 months.
Phase 2: Objective response rate (ORR) .
ORR includes complete response(CR) and partial response (PR), as defined by investigators according to investigators Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) or Immune Response Evaluation Criteria in Solid Tumours (iRECIST) criteria.
Measured: Up to 3 years.
Secondary outcomes (6)
Phase 1 and phase 2: Pharmacokinetics:Number and copy number of CD73/AXL.HypoSti.CAR-T cells .
Number and copy number of CD73/AXL.HypoSti.CAR-T cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD73/AXL.HypoSti.CAR-T cells were not detected for two consecutive times) to detect the number and copy number of CD73/AXL.HypoSti.CAR-T cells, and to evaluate the pharmacokinetics of CD73/AXL.HypoSti.CAR-T.
Measured: Up to 12 months.
Phase 1 and phase 2: Pharmacodynamics: Peak level of cytokines in serum.
The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), C reactive protein (CRP), ferritin. Peak was defined as the maximum post-baseline level of the cytokine.
Measured: Up to 28 days after infusion.
Phase 2:Progression Free Survival (PFS)
PFS is defined as the time from the initiation of CD73/AXL.HypoSti.CAR-T cell therapy to documented disease progression or death.
Measured: Up to 3 years.
Phase 2:Time to response (TTR).
TTR is defined as the time from the initiation of CD73/AXL.HypoSti.CAR-T cell therapy to first assessed CR or PR by investigators according to RECIST 1.1or iRECIST criteria.
Measured: Up to 3 years.
Phase 2:Duration of response (DOR) .
DOR is defined as the time from objective response until documented tumor progression among responders.
Measured: Up to 3 years.
Phase 2:Overall Survival (OS)
OS is defined as the time from the initiation of CD73/AXL.HypoSti.CAR-T cell therapy to documented disease progression or death.
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, Ph.D, Principal investigator, Biotherapeutic Department, Chinese PLA General HospitalJianqing Xu, Ph.D, Study director, Institutes of Biomedical Sciences, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939270
- Sponsor's protocol ID
- CHN-PLAGH-BT-095
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of CD73/AXL Targeted HypoSti.CAR-T Cells in Treating Patients With CD73/AXL Positive Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06939270
- Acronym / sponsor ID
- CHN-PLAGH-BT-095
- Conditions
- Solid Tumor
- Keywords
- CD73/AXL, hypoxia, CAR-T Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 22 Apr 2025 (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.
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses Of CD73/AXL.HypoSti.CAR-T cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Detailed description
Currently, CAR T-cell therapy still faces significant challenges in its application to solid tumors due to multiple obstacles, including the lack of tumor-specific antigens, the complex immunosuppressive tumor microenvironment (TME), tumor heterogeneity, and on targeted/non-targeted (OTOT) toxicity. Previous studies have found that intratumoral hypoxic microenvironment facilitated the development and metastasis of tumor cells. Meanwhile, cytotoxic T cells, including CAR-T cells, struggle to survive and proliferate in this low-oxygen microenvironment.
CD73 (also known as 5'-nucleotidase) and AXL (a receptor tyrosine kinase) are both overexpressed in multiple solid tumors, but less so in normal tissues. They are both involved in regulating tumorigenesis, development, metastasis processes, correlating with inferior prognosis.Dual targeting of CD73 and AXL can effectively address antigen escape and tumor heterogeneity, representing a promising novel immunotherapy strategy.
In this study, combining hypoxia-activated precision with dual-targeting synergy,Investigators have developed a novel CD73/AXL.HypoSti.CAR-T that could effectively expand and survive in hypoxic TME ,offering enhanced efficacy and safety for solid tumors in animal models. Further clinical development is warranted to validate these promising preclinical results. So we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD73/AXL.HypoSti.CAR-T cell in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD73/AXL.HypoSti.CAR-T cell therapy (1 × 10^6 cells/ kg, 3 × 10^6 cells/kg, 1 × 10^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell infusion at RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities (DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD73/AXL.HypoSti.CAR-T cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD73/AXL.HypoSti.CAR-T cells | Experimental | Biological: CD73/AXL.HypoSti.CAR-T cells, Drug: Albumin-Bound Paclitaxel, Drug: Cyclophosphamide, Drug: FludarabineEnrolled participants will be given a preconditioning regimen consisted of albumin-bound paclitaxel, cyclophosphamide and fludarabine before the infusion of CD73/AXL.HypoSti.CAR-T cells. Enrolled patients in this arm will be administered CD73/AXL.HypoSti.CAR-T cells in "3+3" based escalation manner. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18-75 (inclusive).
- The Eastern Cooperative Oncology Group (ECOG) score ≤2 and Estimated life expectancy of more than 3 months.
- Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no National Comprehensive Cancer Network (NCCN) guideline recommended standard firstline therapy. Tumor types include but are not limited to:biliary malignancies, pancreatic cancer, lung cancer, breast cancer, head and neck malignancies, gynecological tumors, etc.
- The expression of CD73 or AXL antigen is≥50%.
- At least one measurable lesion at baseline per RECIST version 1.1.
Key exclusion criteria (14 listed)
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- Received cytotoxic chemicals, monoclonal antibodies, immunotherapy, targeted therapy or other anti-tumor therapy within 4 weeks or 5 half-lives before enrollment.
- Pregnant, lactating, or breastfeeding females.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of allergy or intolerance to study drug components.
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 |
|---|---|---|
| CD73/AXL.HypoSti.CAR-T cellsDose escalation: Dose1 (1×10^6 cells/kg) , Dose 2(3×10^6 cells/kg) ,Dose 3 (1×10^7cells/kg); Dose expansion: RP2D. | Biological | CD73/AXL.HypoSti.CAR-T cells |
| Albumin-Bound PaclitaxelAlso: Albumin-bound paclitaxel for InjectionAdministered intravenously at dose of 100-200mg/m2 on day -5 . | Drug | CD73/AXL.HypoSti.CAR-T cells |
| CyclophosphamideAlso: Cyclophosphamide for InjectionAdministered intravenously at a total dose of 15-30mg/kg on day -3 and day -2 . | Drug | CD73/AXL.HypoSti.CAR-T cells |
| FludarabineAlso: Cyclophosphamide for InjectionAdministered intravenously at dose of 30mg/m2/d on day -3 and day -2. | Drug | CD73/AXL.HypoSti.CAR-T cells |
Primary outcome
Phase 1: Incidence of treatment related adverse events (TRAEs).
Time frame: Up to 12 months
TRAEs are defined as any medical events since the initiation of CD73/AXL.HypoSti.CAR-T cell therapy . Cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be evaluated according to the standards released by American Society for Transplantation and Cellular Therapy (ASTCT) criteria in 2019, and the others will be graded by common terminology criteria for adverse events (CTCAE) V5.0.
Phase 1:Incidence of dose limiting toxicities (DLTs).
Time frame: Up to 28 days after infusion.
DLTs are defined as CD73/AXL.HypoSti.CAR-T cell therapy related adverse events within the first 28 days that meet the following criteria: * Grade 4 CRS or grade 3 CRS that is not resolved to grade 2 or lower within 2 weeks; * Grade 3 ICANS lasting for ≥7 days or Grade 4 ICANS; * Any other Grade ≥4 and Grade 3 AEs related to the CD73/AXL.HypoSti.CAR-T infusion that lasts for ≥14 days, except hematology toxicity.
Phase 1: RP2D
Time frame: Up to 12 months.
The recommended dose for phase 2 was determined through phase 1 study.
Phase 2: Objective response rate (ORR) .
Time frame: Up to 3 years.
ORR includes complete response(CR) and partial response (PR), as defined by investigators according to investigators Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) or Immune Response Evaluation Criteria in Solid Tumours (iRECIST) criteria.
6 secondary outcomes
Phase 1 and phase 2: Pharmacokinetics:Number and copy number of CD73/AXL.HypoSti.CAR-T cells .
Time frame: Up to 12 months.
Phase 1 and phase 2: Pharmacodynamics: Peak level of cytokines in serum.
Time frame: Up to 28 days after infusion.
Phase 2:Progression Free Survival (PFS)
Time frame: Up to 3 years.
Phase 2:Time to response (TTR).
Time frame: Up to 3 years.
Phase 2:Duration of response (DOR) .
Time frame: Up to 3 years.
Phase 2:Overall Survival (OS)
Time frame: Up to 3 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 22 Apr 2025.
- 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.
Weidong Han, Ph.D principal investigator
Biotherapeutic Department, Chinese PLA General Hospital
Jianqing Xu, Ph.D study director
Institutes of Biomedical Sciences, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD73/AXL.HypoSti.CAR-T cells, Albumin-Bound Paclitaxel and Cyclophosphamide in people with Solid Tumor, run by Chinese PLA General Hospital 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 14 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 22 Apr 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Weidong Han, Ph.D (010-66937231 ext. +86, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence of treatment related adverse events (TRAEs). (time frame: Up to 12 months). The study lists 4 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 22 Apr 2025.