Solid Tumor, AdultPhase 1NCT05631886
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
A Phase 1 study testing TP53-EphA-2-CAR-DC, Abraxane and Cyclophosphamide in people with Solid Tumor, Adult and Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult, Lymphoma, EphA2 Overexpression
- What is being tested?
- TP53-EphA-2-CAR-DC, Abraxane and Cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 30 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Local advanced/metastatic solid tumors or R/R lymphomas confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and TP53 mutation (R273H or R175H or R248Q or R249S) within 6 months prior to screening. The second malignancy is allowed.
- No clinical response to standard frontline therapy or no standard therapy exists for solid tumors. Relapse after treatment with ≥2 lines systemic therapy or refractory disease for lymphomas. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for a lack of access need to be documented. Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB.
- At least one measurable lesion at baseline per RECIST version 1.1 or Lugano response criteria 2014.
- Adequate organ function as defined by the following criteria: ANC ≥1000 cells/μL; Platelet count ≥80,000/μL; Hemoglobin ≥8.0 g/dL (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions); Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total serum bilirubin ≤3.0 x ULN); Serum creatinine ≤2 x ULN or creatinine clearance of ≥45 mL/min.
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- Willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.
- Willing to complete all scheduled visits and assessments at the institution administering the therapy.
- Able to read, understand and provide written informed consent.
Who cannot join
- Having TP53 (R273H or R175H or R248Q or R249S) germline mutation.
- Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- 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).
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- Patients with history (within the last 5 years) or risk of autoimmune disease who have immunosuppressive medications or immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) within 28 days prior to enrollment. However, patients who received a short course of corticosteroids (eg, premedication prior to antibody drug) will be eligible for study entry.
- Major trauma or major surgery within 4 weeks prior to enrollment.
- Previous treatment involving TP53 mutant (R273H or R175H or R248Q or R249S) and EphA2.
- Systemic chemotherapy and other intervene within 2 weeks prior to vaccination.
- Being participating or withdrew any other trials within 4 weeks.
- Any serious underlying medical (eg, pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements.
- Vaccination within 30 days of study enrollment.
- Pregnant, lactating, or breastfeeding females.
- 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, 1 recruiting
- Recruiting
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, +86-010-66937463, hanwdrsw69@yahoo.com
About this study
Official title: A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With TP53 Mutant Peptide Plus ICIs for Local Advanced/Metastatic Solid Tumors or Relapsed/Refractory Lymphomas.
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.
Read the detailed description
Therapeutic cancer vaccines, especially DC-based vaccines, are extensively pursued immune approaches in addition to immune checkpoint blockade antibodies and chimeric antigen receptor T cells. DCs can engulf, process and present tumor antigens to T cells, thereby initiating a potent and tumor-specific immune response. However, clinical outcomes of therapeutic cancer vaccines still remain poor, with objective response rates that rarely exceed ~15%. The maturation and activation of DCs are necessary steps to trigger the antitumor responses. However, it is increasingly clear that tumor-infiltrating dendritic cells (TIDCs) usually have an immature or tolerated phenotype that plays central roles in developing tumor microenvironment (TME). As a consequence, malfunction of TIDCs could suppress the infiltration and function of tumor infiltrating T cells and convert them into immune suppressive regulatory T cells.
In our previous research, we constructed novel CAR-DCs (Chimeric antigen receptor engineered dendritic cells) containing a scFv domain targeting EphA2 antigen, CD8a transmembrane, tandem DC-specific activation domains. The engineered CAR-DCs were activated when contacting with tumor targets in TME, and consequently, augmented the cytotoxicity of antigen specific T cells in immune system humanized solid tumor mouse models. Our design of CAR-DCs provides an effective vaccine strategy for malignant tumors. Therefore, we designed an autologous CAR-DC vaccine engineered with anti-EphA2 CAR and TP53 mutant peptide (TP53-EphA-2-CAR-DC), which can suppress the growth of tumors expressing the correlated TP53 mutant in animal models. In addition, the combination of the immune checkpoint inhibitors could further reverse immunosuppressive TME and globally activate T cell responses. In this pilot study, we aim to assess the safety, efficacy and immune response of TP53-EphA-2-CAR-DC combined with anti-PD-1 antibody/anti-CTLA4 antibody in patients with local advanced/metastatic solid tumors or R/R lymphomas.
- Conditions
- Solid Tumor, Adult, Lymphoma, EphA2 Overexpression, TP53 R273H, TP53 R175H, TP53 R248Q
- Being tested
- TP53-EphA-2-CAR-DC, Abraxane, Cyclophosphamide, anti-PD-1 antibody, Anti-CTLA4 Monoclonal Antibody
- Keywords
- Local Advanced/Metastatic, Relapsed/refractory
- Medical subject headings
- Lymphoma, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP53-EphA-2-CAR-DCBiological
5~10 × 10^6 CAR DCs per dose will be administered by intravenous injection.
AbraxaneDrug
Also called Abraxane Injectable Product
Intravenous abraxane 125 mg/m^2/day on day-5.
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Intravenous cyclophosphamide 300 mg/m^2/day on day -4.
anti-PD-1 antibodyDrug
Also called PD-1 blocking antibody
Intravenous anti-PD-1 antibody 200 mg/day.
Anti-CTLA4 Monoclonal AntibodyDrug
Also called Ipilimumab
Intravenous anti-CTLA4 antibody 1 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody | Experimental | In the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and TP53-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1.
In the boost phase, TP53-EphA-2-CAR-DC vaccine is infused one dose every 8 weeks since Week 5.
Anti-PD-1 antibody and anti-CTLA4 antibody are administered 2 days after the first dose of TP53-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 3 weeks afterwards for four doses, followed by anti-PD-1 antibody once every 3 weeks, until:
1. Unacceptable toxicity occurred or disease progression; or 2. Reactive T cells are undetected repeatedly after the last vaccine dose; or 3. Vaccine exhaustion. Receives: Biological: TP53-EphA-2-CAR-DC; Drug: Abraxane; Drug: Cyclophosphamide; Drug: anti-PD-1 antibody; Drug: Anti-CTLA4 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events (AEs)
Determining the safety profile following the initiation of treatment and grading these toxicities by CTCAE v5.0. AEs such as cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: 2 years
Clinical Response
Clinical Response will be determined by iRECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
Measured: 2 years
Immune Response
Immune response will be evaluated by phenotype and functional analysis of vaccine-reactive T cells and Neoantigen-reactive T cells as well as other immune cells in peripheral blood and tumor samples. Response is defined by ≥3 folds increase relative to pre-vaccination.
Measured: Peripheral blood: baseline, weekly before Week 9, prior to each vaccination after Week 9 until last vaccine and 1 year after last vaccine. Tumor tissue: baseline, Week 3, and following timing will be performed according to subject's condition.
Secondary outcomes (6)
Progression Free Survival (PFS)
PFS is defined as the time from TP53-EphA-2-CAR-DCs infusion to documented disease progression or death.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from TP53-EphA-2-CAR-DCs infusion to the date of death.
Measured: 2 years
Time to response (TTR)
TTR is defined as the time from TP53-EphA-2-CAR-DCs infusion to first assessed CR or PR by investigators and based on the iRECIST criteria.
Measured: 2 years
Duration of response (DOR)
DOR is defined as the time from objective response (OR) until documented tumor progression date among responders.
Measured: 2 years
Number and copy number of TP53-EphA-2-CAR-DCs
Number and copy number of TP53-EphA-2-CAR-DCs were assessed by the number in peripheral blood and tumor tissue.
Measured: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the day before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
The level of cytokines in serum
The cytokines mainly include IL-1, IL-2, IL-6, IL-8, IL-10, IL-12 (p70), TNF-α
Measured: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the days before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start4 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Yang Xu, Ph.D, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631886
- Sponsor's protocol ID
- CHN-PLAGH-BT-075
- Status last verified
- Aug 2023
- First submitted
- 21 Nov 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With TP53 Mutant Peptide Plus ICIs for Local Advanced/Metastatic Solid Tumors or Relapsed/Refractory Lymphomas.
- ClinicalTrials.gov ID
- NCT05631886
- Acronym / sponsor ID
- CHN-PLAGH-BT-075
- Conditions
- Solid Tumor, Adult, Lymphoma, EphA2 Overexpression, TP53 R273H, TP53 R175H, TP53 R248Q
- Keywords
- Local Advanced/Metastatic, Relapsed/refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Nov 2022 (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 pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.
Detailed description
Therapeutic cancer vaccines, especially DC-based vaccines, are extensively pursued immune approaches in addition to immune checkpoint blockade antibodies and chimeric antigen receptor T cells. DCs can engulf, process and present tumor antigens to T cells, thereby initiating a potent and tumor-specific immune response. However, clinical outcomes of therapeutic cancer vaccines still remain poor, with objective response rates that rarely exceed ~15%. The maturation and activation of DCs are necessary steps to trigger the antitumor responses. However, it is increasingly clear that tumor-infiltrating dendritic cells (TIDCs) usually have an immature or tolerated phenotype that plays central roles in developing tumor microenvironment (TME). As a consequence, malfunction of TIDCs could suppress the infiltration and function of tumor infiltrating T cells and convert them into immune suppressive regulatory T cells.
In our previous research, we constructed novel CAR-DCs (Chimeric antigen receptor engineered dendritic cells) containing a scFv domain targeting EphA2 antigen, CD8a transmembrane, tandem DC-specific activation domains. The engineered CAR-DCs were activated when contacting with tumor targets in TME, and consequently, augmented the cytotoxicity of antigen specific T cells in immune system humanized solid tumor mouse models. Our design of CAR-DCs provides an effective vaccine strategy for malignant tumors. Therefore, we designed an autologous CAR-DC vaccine engineered with anti-EphA2 CAR and TP53 mutant peptide (TP53-EphA-2-CAR-DC), which can suppress the growth of tumors expressing the correlated TP53 mutant in animal models. In addition, the combination of the immune checkpoint inhibitors could further reverse immunosuppressive TME and globally activate T cell responses. In this pilot study, we aim to assess the safety, efficacy and immune response of TP53-EphA-2-CAR-DC combined with anti-PD-1 antibody/anti-CTLA4 antibody in patients with local advanced/metastatic solid tumors or R/R lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody | Experimental | Biological: TP53-EphA-2-CAR-DC, Drug: Abraxane, Drug: Cyclophosphamide, Drug: anti-PD-1 antibody, Drug: Anti-CTLA4 Monoclonal AntibodyIn the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and TP53-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1. In the boost phase, TP53-EphA-2-CAR-DC vaccine is infused one dose every 8 weeks since Week 5. Anti-PD-1 antibody and anti-CTLA4 antibody are administered 2 days after the first dose of TP53-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 3 weeks afterwards for four doses, followed by anti-PD-1 antibody once every 3 weeks, until: 1. Unacceptable toxicity occurred or disease progression; or 2. Reactive T cells are undetected repeatedly after the last vaccine dose; or 3. Vaccine exhaustion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Local advanced/metastatic solid tumors or R/R lymphomas confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and TP53 mutation (R273H or R175H or R248Q or R249S) within 6 months prior to screening. The second malignancy is allowed.
- No clinical response to standard frontline therapy or no standard therapy exists for solid tumors. Relapse after treatment with ≥2 lines systemic therapy or refractory disease for lymphomas. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for a lack of access need to be documented. Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB.
- At least one measurable lesion at baseline per RECIST version 1.1 or Lugano response criteria 2014.
Key exclusion criteria (15 listed)
- Having TP53 (R273H or R175H or R248Q or R249S) germline mutation.
- Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
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 |
|---|---|---|
| TP53-EphA-2-CAR-DC5~10 × 10^6 CAR DCs per dose will be administered by intravenous injection. | Biological | TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody |
| AbraxaneAlso: Abraxane Injectable ProductIntravenous abraxane 125 mg/m^2/day on day-5. | Drug | TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody |
| CyclophosphamideAlso: Cyclophosphamide for InjectionIntravenous cyclophosphamide 300 mg/m^2/day on day -4. | Drug | TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody |
| anti-PD-1 antibodyAlso: PD-1 blocking antibodyIntravenous anti-PD-1 antibody 200 mg/day. | Drug | TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody |
| Anti-CTLA4 Monoclonal AntibodyAlso: IpilimumabIntravenous anti-CTLA4 antibody 1 mg/kg/day | Drug | TP53-EphA-2-CAR-DC plus anti-PD-1 antibody/anti-CTLA4 antibody |
Primary outcome
Incidence of treatment related adverse events (AEs)
Time frame: 2 years
Determining the safety profile following the initiation of treatment and grading these toxicities by CTCAE v5.0. AEs such as cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Clinical Response
Time frame: 2 years
Clinical Response will be determined by iRECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
Immune Response
Time frame: Peripheral blood: baseline, weekly before Week 9, prior to each vaccination after Week 9 until last vaccine and 1 year after last vaccine. Tumor tissue: baseline, Week 3, and following timing will be performed according to subject's condition.
Immune response will be evaluated by phenotype and functional analysis of vaccine-reactive T cells and Neoantigen-reactive T cells as well as other immune cells in peripheral blood and tumor samples. Response is defined by ≥3 folds increase relative to pre-vaccination.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Number and copy number of TP53-EphA-2-CAR-DCs
Time frame: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the day before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
The level of cytokines in serum
Time frame: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the days before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
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 28 Aug 2023.
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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.
Yang Xu, Ph.D study director
Zhejiang 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 study testing TP53-EphA-2-CAR-DC, Abraxane and Cyclophosphamide in people with Solid Tumor, Adult and Lymphoma, 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 9 inclusion and 15 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 28 Aug 2023. 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 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?
Incidence of treatment related adverse events (AEs) (time frame: 2 years). 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 28 Aug 2023.