Actively Recruiting
A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors
Led by Ever Supreme Bio Technology Co., Ltd. · Updated on 2024-12-03
60
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).
CONDITIONS
Official Title
A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- For phase I: solid tumor with PD-L1 expression of 1% or higher and relapsed/refractory after at least two standard treatments
- For phase IIa: diagnosis of triple negative breast cancer, non-small cell lung cancer, colorectal cancer, or glioblastoma multiforme with PD-L1 expression of 1% or higher and relapsed/refractory after at least two standard treatments
- At least one measurable tumor lesion by RECIST1.1 (for TNBC, NSCLC or CRC) or RANO (for GBM)
- Able to understand and sign the informed consent form
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Recovery from any prior therapy-related side effects to grade 2 or less at screening
- Adequate kidney function: serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) over 50 ml/min
- Adequate liver function: ALT, AST, and ALP less than or equal to 3 times ULN or 5 times ULN if liver metastases; total bilirubin less than or equal to 1.5 times ULN or 3 times ULN if due to Gilbert's disease
- Prothrombin time (PT) and partial thromboplastin time (PTT) less than or equal to 1.5 times ULN
- Adequate blood cell counts: absolute neutrophil count at least 1,000 cells/µl; platelets at least 75,000 counts/µl; total white blood cells at least 2,000 cells/µl; hemoglobin at least 8 g/dL
You will not qualify if you...
- Prior receipt of any allogeneic cell therapy before screening
- Known or suspected allergy to CAR001 or its components such as DMSO or human serum albumin
- More than one active primary cancer diagnosed
- Active infection requiring systemic medication
- Use of systemic steroids over 10 mg prednisone/day or equivalent, or other immune suppressants within past 2 weeks
- HIV positive diagnosis confirmed by tests
- Acute cardiovascular disease, New York Heart Association (NYHA) class 3 or higher, recent myocardial infarction within 6 months, or uncontrolled high blood pressure
- History or presence of autoimmune diseases like rheumatoid arthritis, type 1 diabetes, psoriasis, or lupus
- Uncontrolled psychiatric disorders
- Central nervous system diseases except glioblastoma multiforme or stroke
- Participation in another clinical trial with investigational therapy within 4 weeks
- Unable to undergo radiological assessments such as MRI or CT
- Radiotherapy or chemotherapy within 2 weeks (except palliative radiation for pain control)
- Deemed unsuitable for trial participation by the investigator
- Female of childbearing potential who is breastfeeding, pregnant, or refuses at least two forms of birth control from consent until 1 year after last CAR001 dose
- Male with female partner of childbearing potential who refuses at least two forms of birth control from consent until 1 year after last CAR001 dose
- Acceptable birth control methods include hormonal contraception, intrauterine device or system, and barrier methods such as condoms or diaphragms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Non-US, Taiwan, 404
Actively Recruiting
Research Team
S
Sammi Hsu
CONTACT
V
Vincent Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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