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Brief Title: 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.

INTRODUCTION

  • Org Study ID: CCT301-59-mST01
  • Secondary ID: N/A
  • NTC ID: NCT03960060
  • Sponsor: Shanghai Sinobioway Sunterra Biotech

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.


  • Overall Status
    Recruiting
  • Start Date
    May 16, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety of CCT301-59 CAR T cell therapy

Primary Outcome 1 - Timeframe: Up to 52 weeks

Primary Outcome 2 - Measure: Efficacy of CCT301-59 CAR T cell therapy

Primary Outcome 2 - Timeframe: Up to 52 weeks

Primary Outcome 3 - Measure: Kinetics of CAR T cells

Primary Outcome 3 - Timeframe: Up to 52 weeks

CONDITION

  • Solid Tumor
  • Soft Tissue Sarcoma
  • Gastric Cancer
  • Pancreatic Cancer
  • Bladder Cancer

ELIGIBILITY


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;

- 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;

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;

10. Subjects with other active malignant tumors in the past five years including basal or
squamous cell skin cancer, superficial bladder cancer or in situ breast cancer who
have been completely cured, and without any follow-up treatment are not included;

11. Current using of systemic steroid or steroid inhalant;

12. Have used of immunotherapy treatment in the past three months or PD-1 (Programmed cell
death protein 1) antibody, PD-L1 (Programmed death-ligand 1) antibody, PD-L2 antibody,
CD137 (tumor necrosis factor receptor superfamily member 9, 4-1BB) antibody or CTLA-4
(cytotoxic T-lymphocyte-associated protein 4) antibody, or cell therapy.

13. Allergy to immunotherapy or relevant medications;

14. Meningeal metastasis or central nervous system metastasis in the last 6 months, with
obvious underlying diseases of the central nervous system, and leaving obvious
symptoms;

15. Subjects with NYHA (New York Heart Association) heart failure grade ≥ 2 or
uncontrollable hypertension by standard treatment and requiring special treatment, or
with history of myocarditis, or occurrence of myocardial infarction within one year;

16. Previous organ transplantation or be ready for organ transplantation;

17. Pancreatic cancer with pancreatitis;

18. Active bleeding;

19. Subjects with pleural effusion or abdominal effusion that require clinical treatment
or intervention;

20. Being judged by investigators as inappropriate to participate in this study.

Gender: All

Minimum Age: 70 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Yuhong Zhou

Role: Principal Investigator

Affiliation: Shanghai Zhongshan Hospital

Overall Contact

Name: Yuhong Zhou

Phone: 86 21 64041990

Email: zhou.yuhong@zs-hospital.sh.cn

LOCATION

Facility Status Contact
Facility: Shanghai Zhongshan Hospital
Shanghai, Shanghai 200032
China
Status: Recruiting Contact:
Yuhong Zhou
86 21 64041990
zhou.yuhong@zs-hospital.sh.cn