A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors
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ClinicalTrials.gov Identifier: NCT04511871 |
Recruitment Status :
Recruiting
First Posted : August 13, 2020
Last Update Posted : April 18, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | August 10, 2020 | ||||||||
First Posted Date ICMJE | August 13, 2020 | ||||||||
Last Update Posted Date | April 18, 2023 | ||||||||
Actual Study Start Date ICMJE | July 9, 2020 | ||||||||
Estimated Primary Completion Date | March 29, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
MTD: to determine the maximum tolerated dose of CCT303-406 [ Time Frame: 28 days following infusion ] To assess the DLT (dose limiting toxicities) attributed to CCT303-406 per cohort and determine the RP2D (recommended phase 2 dose).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Exploration of target-efficacy correlation [ Time Frame: Up to 52 weeks ] The correlation between levels of HER2 expression and ORR
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||||
Brief Title ICMJE | A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors | ||||||||
Official Title ICMJE | A Phase I Trial to Assess Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) (CCT303-406) in Patients With Relapsed or Refractory HER2 Positive Solid Tumors | ||||||||
Brief Summary | This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors. | ||||||||
Detailed Description | This is a single arm, open label, dose escalation clinical study to evaluate the safety and preliminary therapeutic efficacy of CCT303-406 cells in adult subjects with HER2 positive relapsed or refractory stage IV metastatic solid tumors. Subjects that meet inclusion criteria with positive biopsy HER2 (IHC 3+ in ≥50% tumor cells) will receive CCT303-406 according to the 3+3 dose escalation design. |
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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: CCT303-406
Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT303-406. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single dose of CCT303-406 via intravenous injection.
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Study Arms ICMJE | Experimental: CCT303-406
To determine the safety, tolerability, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of CCT303-406 cell therapy in patients with HER2-positive (IHC 3+ in ≥50% tumor cells) relapsed or refractory solid tumors. Dose cohorts:
Intervention: Biological: CCT303-406
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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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
15 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 29, 2025 | ||||||||
Estimated Primary Completion Date | March 29, 2024 (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 |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04511871 | ||||||||
Other Study ID Numbers ICMJE | CCT303-406-mST01 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Shanghai PerHum Therapeutics Co., Ltd. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Shanghai PerHum Therapeutics Co., Ltd. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Shanghai Zhongshan Hospital | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Shanghai PerHum Therapeutics Co., Ltd. | ||||||||
Verification Date | April 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |