A Study Of CCT301-59 CAR T Therapy In Adult Subjects With Recurrent Or Refractory Solid Tumors

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-05-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-24
First Submitted that Met QC Criteria 2019-05-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-28
First Posted (ACTUAL) 2019-05-22	Results First Posted N/A	Last Verified 2021-10

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 C	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 CC

Participant Group/Arm

Intervention/Treatment

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 C

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 CC

Primary Outcome Measures	Measure Description	Time Frame
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.	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.	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.	Up to 52 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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); 9. Prothrombin time (PT): INR (International Normalized Ratio) <1.7 or prolonged, PT prolonged < 4 seconds from normal level; 10. Normal neurologic evaluation; 11. Sufficient venous access for venous intravenous blood collection and infusion, no other contraindications for blood cell separation; 12. Able to receive treatment and follow-up, including the treatment at the enrolled site; 13. 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;

Collaborators and Investigators

Publications

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Resources

Patients

Caregivers

Clinical Trial Record