Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Soft Tissue Sarcoma Gastric Cancer Pancreatic Cancer Bladder Cancer | Biological: CCT301-59 | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | May 16, 2019 |
Estimated Primary Completion Date : | February 28, 2021 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
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Experimental: CCT301-59
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.
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Biological: CCT301-59
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.
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The organ and hematopoietic functions must meet the following requirements:
Exclusion Criteria:
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);
China, Shanghai | |
Shanghai Zhongshan Hospital | |
Shanghai, Shanghai, China, 200032 |
Principal Investigator: | Yuhong Zhou | Shanghai Zhongshan Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 8, 2019 | ||||
First Posted Date ICMJE | May 22, 2019 | ||||
Last Update Posted Date | July 7, 2020 | ||||
Actual Study Start Date ICMJE | May 16, 2019 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors | ||||
Official Title ICMJE | 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. | ||||
Brief 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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: CCT301-59
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.
|
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Study Arms ICMJE | Experimental: CCT301-59
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.
Intervention: Biological: CCT301-59
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
18 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03960060 | ||||
Other Study ID Numbers ICMJE | CCT301-59-mST01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Shanghai PerHum Therapeutics Co., Ltd. | ||||
Study Sponsor ICMJE | Shanghai PerHum Therapeutics Co., Ltd. | ||||
Collaborators ICMJE | Shanghai Zhongshan Hospital | ||||
Investigators ICMJE |
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PRS Account | Shanghai PerHum Therapeutics Co., Ltd. | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |