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TERMINATEDPHASE1

A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors

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.

NCT03960060•Shanghai PerHum Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.
•2. Male or female subjects 18-70 years of age.
•3. 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.
•4. 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).
•5. 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.
•6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.
•7. Expected survival will be ≥ 12 weeks.
•8. 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;
+10 more criteria

Exclusion Criteria

•1. Pregnant or breastfeeding female subjects;
•2. Active infection of hepatitis B, or active hepatitis C;
•3. Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome);
•4. Other active infection with clinical significance;
•5. 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);
•6. Subjects with previous diagnosis as motor neuron disease;
•7. Subjects with previous disease of toxic epidermal necrolysis;
•8. Having any mental disorder that may affect the understanding of informed consent and relevant questionnaires, including dementia, altered mental status;
•9. Having serious uncontrollable disease judged in the study that may affect the subjects receiving the study treatment;
+11 more criteria

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 16, 2019

Primary Completion Date

June 30, 2022

Completion Date

June 30, 2023

Last Updated

October 28, 2024

Enrollment

ACTUAL participants

Conditions

Solid TumorSoft Tissue SarcomaGastric CancerPancreatic CancerBladder Cancer

Interventions

CCT301-59

BIOLOGICAL

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of CCT301-59 CAR T Therapy in Adult Subjects With Recurrent or Refractory Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Study of PYX-201 in Advanced Solid Tumors

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