Solid TumorPhase 1CARNCT03960060
A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors
A Phase 1 study testing CCT301-59 in people with Solid Tumor and Soft Tissue Sarcoma, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This clinical study is to investigate the safety and tolerability of CAR modified autologous T cells (CCT301-59) in subjects with recurrent or refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Soft Tissue Sarcoma, Gastric Cancer
- What is being tested?
- CCT301-59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2019to 30 Jun 2023
- Phase
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.
- Male or female subjects 18-70 years of age.
- Subjects are diagnosed as recurrent or refractory solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer) with identified unresectable advanced or metastatic tumors by radiology and histology or cytology, progression after the first line or above treatment, or intolerance to standard treatment.
- At least one measurable lesion in accordance with RECIST 1.1, the long diameter of non-lymph node lesions ≥10mm (millimeter) according to CT (computerized tomography) scan-sectional image, or the short diameter of lymph node lesions ≥15mm; the longest axis of the measurable lesion ≥10 mm in CT scan (CT scan layer ≤ 5mm); FDG PET (fluorodeoxyglucose -positron emission tomography) of the measurable lesion > 3 SUV (standardized uptake values).
- Subjects with ROR2 positive tumor tissue: the percentage of ROR2 positive staining cells in tumor cells detected by immunohistochemistry or RNA (Ribonucleic acid) in situ hybridization is ≥ 50%. The samples could be used within one year , otherwise the sample will be re-collected for biopsy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.
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- Expected survival will be ≥ 12 weeks.
- The organ and hematopoietic functions must meet the following requirements:
- Hemoglobin (HGB)≥90 g/L (gram per litre), no blood transfusion within two weeks;
- White blood cell count (WBC) ≥ 2.5×10^9/L;
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
- Platelet count (PLT) ≥ 80×10^9/L;
- Total bilirubin (TBIL) ≤ 3.0ng/dL or ≤ 5 ULN (Upper Limit of Normal);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; AST and ALT≤ 5×ULN in case the abnormal hepatic function is caused by hepatocellular carcinoma or liver metastasis from other tumors;
- Serum creatinine (Cr) ≤ 1.5×ULN; or creatinine clearance (CrCl) ≥ 50 mL/min (milliliter per minute);
- Prothrombin time (PT): INR (International Normalized Ratio) <1.7 or prolonged, PT prolonged < 4 seconds from normal level;
- Normal neurologic evaluation;
- Sufficient venous access for venous intravenous blood collection and infusion, no other contraindications for blood cell separation;
- Able to receive treatment and follow-up, including the treatment at the enrolled site;
- Female subjects of childbearing age must take acceptable measures to minimize the possibility of pregnancy during the trial. The serum or urine pregnancy test must be negative prior to pre-treatment for female subjects of childbearing age;
Who cannot join
- Pregnant or breastfeeding female subjects;
- Active infection of hepatitis B, or active hepatitis C;
- Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome);
- Other active infection with clinical significance;
- Previous diseases or concurrent diseases:
- Subjects diagnosed as serious autoimmune disease in long-term (over two months) requirement of systemic immunosuppressant (steroid), or as immune mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis);
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- Subjects with previous diagnosis as motor neuron disease;
- Subjects with previous disease of toxic epidermal necrolysis;
- Having any mental disorder that may affect the understanding of informed consent and relevant questionnaires, including dementia, altered mental status;
- Having serious uncontrollable disease judged in the study that may affect the subjects receiving the study treatment;
- Subjects with other active malignant tumors in the past five years including basal or squamous cell skin cancer, superficial bladder cancer or in situ breast cancer who have been completely cured, and without any follow-up treatment are not included;
- Current using of systemic steroid or steroid inhalant;
- Have used of immunotherapy treatment in the past three months or PD-1 (Programmed cell death protein 1) antibody, PD-L1 (Programmed death-ligand 1) antibody, PD-L2 antibody, CD137 (tumor necrosis factor receptor superfamily member 9, 4-1BB) antibody or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) antibody, or cell therapy.
- Allergy to immunotherapy or relevant medications;
- Meningeal metastasis or central nervous system metastasis in the last 6 months, with obvious underlying diseases of the central nervous system, and leaving obvious symptoms;
- Subjects with NYHA (New York Heart Association) heart failure grade ≥ 2 or uncontrollable hypertension by standard treatment and requiring special treatment, or with history of myocarditis, or occurrence of myocardial infarction within one year;
- Previous organ transplantation or be ready for organ transplantation;
- Pancreatic cancer with pancreatitis;
- Active bleeding;
- Subjects with pleural effusion or abdominal effusion that require clinical treatment or intervention;
- Being judged by investigators as inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of CAR (Chimeric Antigen Receptor) Modified Autologous T Cell CCT301-59 in Patients With Recurrent or Refractory Solid Tumors on the Basis of Safety, Tolerability and Anti-tumor Activity Study.
This clinical study is to investigate the safety and tolerability of CAR modified autologous T cells (CCT301-59) in subjects with recurrent or refractory solid tumors.
Read the detailed description
This is a single arm, open label, dose escalation clinical study to evaluate the safety and preliminary therapeutic efficacy of CCT301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer, bladder cancer etc.).
The subjects with ROR2 (receptor tyrosine kinase-like orphan receptor 2) positive biopsy will receive CCT301-59.
According to the 3+3 rules during the dose escalation stage to receive CCT301-59 treatment.
- Being tested
- CCT301-59
- Medical subject headings
- Sarcoma, Stomach Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCT301-59Biological
Collect blood from the patients and isolate peripheral blood mononuclear cells for the production of CCT301-59. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion during the production of CCT301-59 and then subjects will receive one dose of CCT301-59 via intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| CCT301-59 | Experimental | The safety and preliminary therapeutic efficacy of CCT301-59 will be evaluated for subjects with ROR2 positive biopsy in a standard 3+3 dose escalation rule. Three dose levels of CAR T will be administered in this study: 1x10^6, 3x10^6, 1x10^7 CCT301-59 CAR positive T cells/kg weight, intravenous infusion. Receives: Biological: CCT301-59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CCT301-59 CAR T cell therapy
To observe the safety of CCT301-59 CAR positive T cells in subjects using Common Toxicity Criteria for Adverse effects (CTCAE) version 5.0.
Measured: Up to 52 weeks
Efficacy of CCT301-59 CAR T cell therapy
Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Measured: Up to 52 weeks
Kinetics of CAR T cells
The level of CAR T cells in the peripheral blood and persistence of CAR T cells in patients will be tested.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start16 May 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Why it stopped: Adjustment of study strategy
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.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai PerHum Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Yuhong Zhou, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960060
- Sponsor's protocol ID
- CCT301-59-mST01
- Acronym
- CAR
- Status last verified
- Oct 2021
- First submitted
- 8 May 2019
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CAR (Chimeric Antigen Receptor) Modified Autologous T Cell CCT301-59 in Patients With Recurrent or Refractory Solid Tumors on the Basis of Safety, Tolerability and Anti-tumor Activity Study.
- ClinicalTrials.gov ID
- NCT03960060
- Acronym / sponsor ID
- CAR / CCT301-59-mST01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of study strategy
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shanghai PerHum Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 16 May 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 May 2019 (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 clinical study is to investigate the safety and tolerability of CAR modified autologous T cells (CCT301-59) in subjects with recurrent or refractory solid tumors.
Detailed description
This is a single arm, open label, dose escalation clinical study to evaluate the safety and preliminary therapeutic efficacy of CCT301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer, bladder cancer etc.).
The subjects with ROR2 (receptor tyrosine kinase-like orphan receptor 2) positive biopsy will receive CCT301-59.
According to the 3+3 rules during the dose escalation stage to receive CCT301-59 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCT301-59 | Experimental | Biological: CCT301-59The safety and preliminary therapeutic efficacy of CCT301-59 will be evaluated for subjects with ROR2 positive biopsy in a standard 3+3 dose escalation rule. Three dose levels of CAR T will be administered in this study: 1x10^6, 3x10^6, 1x10^7 CCT301-59 CAR positive T cells/kg weight, intravenous infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.
- Male or female subjects 18-70 years of age.
- Subjects are diagnosed as recurrent or refractory solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer) with identified unresectable advanced or metastatic tumors by radiology and histology or cytology, progression after the first line or above treatment, or intolerance to standard treatment.
- At least one measurable lesion in accordance with RECIST 1.1, the long diameter of non-lymph node lesions ≥10mm (millimeter) according to CT (computerized tomography) scan-sectional image, or the short diameter of lymph node lesions ≥15mm; the longest axis of the measurable lesion ≥10 mm in CT scan (CT scan layer ≤ 5mm); FDG PET (fluorodeoxyglucose -positron emission tomography) of the measurable lesion > 3 SUV (standardized uptake values).
- Subjects with ROR2 positive tumor tissue: the percentage of ROR2 positive staining cells in tumor cells detected by immunohistochemistry or RNA (Ribonucleic acid) in situ hybridization is ≥ 50%. The samples could be used within one year , otherwise the sample will be re-collected for biopsy.
Key exclusion criteria (21 listed)
- Pregnant or breastfeeding female subjects;
- Active infection of hepatitis B, or active hepatitis C;
- Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome);
- Other active infection with clinical significance;
- Previous diseases or concurrent diseases:
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 |
|---|---|---|
| CCT301-59Collect blood from the patients and isolate peripheral blood mononuclear cells for the production of CCT301-59. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion during the production of CCT301-59 and then subjects will receive one dose of CCT301-59 via intravenous injection. | Biological | CCT301-59 |
Primary outcome
Safety of CCT301-59 CAR T cell therapy
Time frame: Up to 52 weeks
To observe the safety of CCT301-59 CAR positive T cells in subjects using Common Toxicity Criteria for Adverse effects (CTCAE) version 5.0.
Efficacy of CCT301-59 CAR T cell therapy
Time frame: Up to 52 weeks
Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Kinetics of CAR T cells
Time frame: Up to 52 weeks
The level of CAR T cells in the peripheral blood and persistence of CAR T cells in patients will be tested.
Results and safety
The study was stopped early (reason given: Adjustment of study strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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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.
Yuhong Zhou principal investigator
Shanghai Zhongshan Hospital
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 CCT301-59 in people with Solid Tumor and Soft Tissue Sarcoma, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Oct 2024. 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?
The study was stopped early (reason given: Adjustment of study strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CCT301-59 CAR T cell therapy (time frame: Up to 52 weeks). 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 Oct 2024.