Actively Recruiting
Repeat Intravenous Infusions of B4T2-001 CAR-T Without Lymphodepleting Chemotherapy for Solid Tumors
Led by Shanghai East Hospital · Updated on 2023-10-10
24
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
Sponsors
S
Shanghai East Hospital
Lead Sponsor
B
Bio4T2 LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of autologous B4T2-001 CAR-T in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC). The trial builds off first-in-human results from pilot study per clinicaltrials.gov ID: NCT05621486 to administer multiple infusions of B4T2-001 CAR-T without the need to give preparative chemotherapy (lymphodepletion).
CONDITIONS
Official Title
Repeat Intravenous Infusions of B4T2-001 CAR-T Without Lymphodepleting Chemotherapy for Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- ECOG performance status of 0 or 1
- Expected survival longer than 3 months
- Histologically or cytologically confirmed locally advanced or metastatic BT-001 positive solid tumors
- BT-001 positivity confirmed by Immunohistochemistry within 6 months before cell collection
- Preferably patients who have failed first- or second-line therapy
- Measurable lesions according to RECIST 1.1 criteria
- Maximum tumor size less than 4 cm
- Adequate bone marrow, liver, kidney, and lung function based on clinical trial site standards
- Absolute neutrophil count and platelet count at or above lower limit of normal
- Liver enzymes within specified limits depending on liver metastases status
- Serum creatinine ≤1.5 times upper limit of normal or creatinine clearance >50 mL/min
- Coagulation parameters within acceptable limits
- Oxygen saturation ≥95% without oxygen support
- Male or female patients of childbearing potential agree to use effective contraception during study and for 1 year after infusion
You will not qualify if you...
- Recent cytotoxic chemotherapy within 14 or 28 days depending on toxicity
- Recent targeted small molecule therapy within 14 days or five half-lives
- Recent monoclonal antibody therapy within 21 days
- Recent immune checkpoint inhibitor or Avastin therapy within 30 days
- Recent immunomodulatory therapy within 14 days
- Recent radiotherapy within 14 days
- Recent anti-tumor traditional Chinese medicine within 14 days
- Recent investigational agents within 28 days
- Prior treatment with CAR-T/TCR-T cells or vaccines within 28 days
- Previous treatment with BT-001-targeted therapy
- Brain metastases with central nervous system symptoms
- Pregnant or breastfeeding
- Allergies to study-related drugs or excipients
- Positive hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- Interstitial lung disease or pneumonia, multiple lung metastases or large lung lesions
- Uncontrolled active infections
- Major surgery within 2 weeks prior to cell collection and not fully recovered
- Ongoing significant toxicity from prior cancer therapy above specified levels
- Recent history of serious cardiovascular events or heart failure class 2 or higher
- Recent systemic corticosteroid or immunosuppressant use above specified doses
- Autoimmune diseases or Crohn's disease
- History of uncontrollable mental illness
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai East Hospital
Shanghai, China/Shanghai, China, 200126
Actively Recruiting
2
Shanghai Artemed Hospital
Shanghai, China/Shanghai, China, 200131
Actively Recruiting
Research Team
J
Jin Li, MD,PhD
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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