OsteosarcomaEarly Phase 1NCT04864821
Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor
A Early Phase 1 study testing Targeting CD276 CAR T cells in people with Osteosarcoma and Neuroblastoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Trial summary
Cd276 (B7-H3) is an ideal target for car-t treatment because of its high expression on the surface of neuroblastoma, osteosarcoma, gastric cancer and lung cancer cells, but not in normal peripheral cells or tissues. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Osteosarcoma, Neuroblastoma, Gastric Cancer
- What is being tested?
- Targeting CD276 CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2021to 14 May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients were aged from 1 to 70 years old (including the cut-off value), and the gender was not limited;
- The expected survival time was more than 12 weeks;
- ECoG score was 0-2;
- One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of cd276 expression in tumor tissue was more than 50% by immunohistochemistry;
- Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
- According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion ≥ 10 mm, or the short diameter of lymph node lesion ≥ 15 mm);
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- The function of main organs was normal (white blood cell count ≥ 3 × 109 / L, neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 8.5g/dl, platelet count ≥ 80 × 109 / L and lymphocyte count at 1 × 109 / L (including) ~ 4 × 109 / L (inclusive);
- The liver and kidney function and cardiopulmonary function meet the following requirements:
- Urea and serum creatinine ≤ 1.5 × ULN；
- Left ventricular ejection fraction ≥ 50%;
- Baseline oxygen saturation ≥ 94%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN；
- The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.
Who cannot join
- Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- There was a history of other second malignancies in 5 years before screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
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- Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;
- Patients who had received car-t therapy or other gene modified cell therapy before screening;
- The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;
- The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
- According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- Other researchers think that it is not suitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Cd276 (B7-H3) is an ideal target for car-t treatment because of its high expression on the surface of neuroblastoma, osteosarcoma, gastric cancer and lung cancer cells, but not in normal peripheral cells or tissues. In conclusion, car-t cell therapy has achieved exciting results in blood tumors, but it has been stopped in solid tumor. The main reason for the poor effect is the existence of tumor microenvironment of solid tumor, which inhibits the chemotaxis and infiltration of car-t cells to tumor site. Therefore, in this clinical experiment, we will explore the best model of car-t therapy for solid tumor by intravenous and local tumor injection, which will bring new hope to patients with osteosarcoma, neuroblastoma and gastric cancer
- Conditions
- Osteosarcoma, Neuroblastoma, Gastric Cancer, Lung Cancer
- Being tested
- Targeting CD276 CAR T cells
- Medical subject headings
- Osteosarcoma, Neuroblastoma, Stomach Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting CD276 CAR T cellsDrug
Targeting CD276 autologous chimeric antigen receptor T cells
| Study group | Role | What they receive |
|---|---|---|
| T cell injection targeting CD276 chimeric antigen receptor | Other | Not described Receives: Drug: Targeting CD276 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
adverse event
Measured: 2 years after treatment
ORR
Objective remission rate
Measured: 12 weeks after treatment
Cmax
The highest concentration of CAR-T cells in peripheral blood after infusion
Measured: 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start14 May 2021 (estimated)
- Primary completion14 May 2022 (estimated)
- Study completion14 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864821
- Sponsor's protocol ID
- PA-P276-001
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 6 May 2021
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04864821
- Acronym / sponsor ID
- PA-P276-001
- Conditions
- Osteosarcoma, Neuroblastoma, Gastric Cancer, Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 14 May 2021 (estimated)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 14 May 2023 (estimated)
- First posted
- 29 Apr 2021 (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.
Cd276 (B7-H3) is an ideal target for car-t treatment because of its high expression on the surface of neuroblastoma, osteosarcoma, gastric cancer and lung cancer cells, but not in normal peripheral cells or tissues. In conclusion, car-t cell therapy has achieved exciting results in blood tumors, but it has been stopped in solid tumor. The main reason for the poor effect is the existence of tumor microenvironment of solid tumor, which inhibits the chemotaxis and infiltration of car-t cells to tumor site. Therefore, in this clinical experiment, we will explore the best model of car-t therapy for solid tumor by intravenous and local tumor injection, which will bring new hope to patients with osteosarcoma, neuroblastoma and gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T cell injection targeting CD276 chimeric antigen receptor | Other | Drug: Targeting CD276 CAR T cells |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- The patients were aged from 1 to 70 years old (including the cut-off value), and the gender was not limited;
- The expected survival time was more than 12 weeks;
- ECoG score was 0-2;
- One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of cd276 expression in tumor tissue was more than 50% by immunohistochemistry;
- Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
Key exclusion criteria (12 listed)
- Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- There was a history of other second malignancies in 5 years before screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
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 |
|---|---|---|
| Targeting CD276 CAR T cellsTargeting CD276 autologous chimeric antigen receptor T cells | Drug | T cell injection targeting CD276 chimeric antigen receptor |
Primary outcome
AE
Time frame: 2 years after treatment
adverse event
ORR
Time frame: 12 weeks after treatment
Objective remission rate
Cmax
Time frame: 2 years after treatment
The highest concentration of CAR-T cells in peripheral blood after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Targeting CD276 CAR T cells in people with Osteosarcoma and Neuroblastoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, Doctor (+8615138928971, 1248135168@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: 2 years after treatment). 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 6 May 2021.