Status:
ACTIVE_NOT_RECRUITING
A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors
Lead Sponsor:
Shanghai PerHum Therapeutics Co., Ltd.
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Conditions:
Solid Tumor
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 s...
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 refrac...
Eligibility Criteria
Inclusion
- Patients with willingness to be in the study and follow all study procedures, and capable of providing informed consent
- Male or female aged 18-70 years
- Patients with stage IV (according to the 8th edition of AJCC) advanced solid tumor malignancies that have failed standard treatment of relapsed or difficult-to-treat solid tumors confirmed by histology or cytology
- At least one measurable lesion, i.e. the length of non-lymph node lesions examined according to CT cross-sectional scanning or magnetic resonance imaging (MRI), or the short diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1
- Tumors with HER2 IHC 3+ in≥50% of all tumor cells as determined by IHC according to the Breast Cancer HER2 Testing (2019 edition) and the Gastric Cancer HER2 Testing (2016 edition); For HER2 IHC 3+ tumors other than gastric and breast cancers, FISH is required to confirm HER2 expression; For relapsed patients after HER2-targeted therapies, biopsy and IHC are required to confirm HER2 expression per enrollment criteria.
- ECOG Performance Status 0-1
- Expected survival greater than 12 weeks
- Adequate organ and hematopoietic system functions to meet the following requirements:
- Hemoglobin (HGB) s 90 g/L, no blood transfusions within two weeks;
- White blood cell (WBC) count≥2.5×109/L
- Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
- Platelet (PLT) count ≥80-109/L
- Total bilirubin (TBIL) ≤3.0ng/dL or ≤5 ULN
- ALT and AST ≤5 ULN; for liver metastasis, ALT and AST ≤5 ULN
- Creatinine (Cr) ≤1.5 x ULN; or creatinine removal rate (CrCl) ≥50 mL/min
- LVEF≥50%
- Serum troponin T \<0.03 ng/mL
- PT: INR \< 1.7 or extended PT to normal value \< 4s
- Normal language, recognition and consciousness assessed by investigator during screening phase
- Capable of receiving treatment and follow-up, including treatment in the clinical center;
- Female subjects of childbearing age must take acceptable measures to minimize the likelihood of pregnancy during the trial. The results of serum or urine pregnancy test must be negative
- Female subjects must not be in the lactation period.
Exclusion
- Females with pregnancy or in lactation period
- Patients with active hepatitis B, or active hepatitis C
- HIV positive
- Other active infections of clinical significance
- Patients receiving in situ surgery within 3 months
- Patients with the following previous or accompanying diseases:
- • Patients diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases with immune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis
- Patients with ≥Grade 2 peripheral neuronal diseases (according to NCI-CTCAE v5.0)
- Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires
- Patients with serious uncontrollable diseases, which may interfere with the therapies in this study
- Patients with other active malignancies in the past 5 years excluding those with completely cured basal or squamous skin cancers, superficial bladder cancers or primary breast cancers without need of follow-up treatment
- Patients receiving systemic steroids or steroid inhalants
- Patients who have received tumor immunotherapy (including monoclonal antibody or cell therapy) in the past 4 weeks
- Patients allergic to immunotherapies or related drugs
- Patients with metastatic lesions in meninges or central nervous system, or clear evidence of central nervous system diseases with continous significant symptoms in the last 6 months
- Patients with NYHA class II heart failure, or hypertension incontrollable by standard care, or medical history of myocarditis, or heart attack within a year
- Patients who have received or are going to receive organ transplantation
- Patients with active bleeding
- Patients with incontrollable pleural or abdominal fluid that needs clinical treatment or intervention
- Patients having undergone major surgery within 4 weeks or have not fully recovered from prior surgery
- Patients that have received radiotherapy within 4 weeks, excluding those who received local irradiation for the peripheral bone metastatic lesions for more than 2 weeks, and recovered from all acute toxicities of radiotherapy
- Patients that have received anthracyclines within 8 weeks
- Patients as determined by the investigators to be inappropriate for the study
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04511871
Start Date
July 9 2020
End Date
March 29 2025
Last Update
October 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032