A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors (CAR)
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|ClinicalTrials.gov Identifier: NCT03960060|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960060
|Contact: Yuhong Zhou||86 21 64041990 ext firstname.lastname@example.org|
|Contact: Hongliang Zongemail@example.com|
|Shanghai Zhongshan Hospital||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Yuhong Zhou 86 21 64041990 ext 2968 firstname.lastname@example.org|
|Contact: Hongliang Zong +8613817903385 zonghl@PerHum.com|
|Principal Investigator: Yuhong Zhou|
|Principal Investigator:||Yuhong Zhou||Shanghai Zhongshan Hospital|