Actively Recruiting
HS-IT101 Injection in the Treatment of Advanced Solid Tumors
Led by Qingdao Sino-Cell Biomedicine Co., Ltd. · Updated on 2024-04-02
44
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
Q
Qingdao Sino-Cell Biomedicine Co., Ltd.
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.
CONDITIONS
Official Title
HS-IT101 Injection in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent
- Diagnosed with advanced solid tumor by histology or cytology
- Have at least one resectable lesion not treated with radiotherapy or local therapy within 28 days, and tissue weight ≥ 0.050g or capable of producing sufficient TIL
- Have at least one measurable target lesion per RECIST v1.1 that has not had recent radiotherapy or local therapy unless progressed significantly
- ECOG performance status of 0-1
- Expected lifespan greater than 3 months
- Adequate organ and bone marrow function with specified blood counts and biochemical parameters
- Left ventricular ejection fraction ≥ 50% with normal heart rhythm measures
- Recovered from prior therapy-related toxicities to grade ≤ 1 except alopecia
- Willing to use effective contraception during study and for 1 year after treatment if of child-bearing potential
- Able to understand and sign informed consent
You will not qualify if you...
- History of hypersensitivity to HS-IT101 components or study drugs (cyclophosphamide, fludarabine, IL-2)
- Uncontrolled clinical problems such as poorly controlled hypertension, diabetes, or significant cardiac disease
- Active major cardiovascular illnesses within 6 months prior to enrollment
- Active autoimmune diseases requiring systemic treatment (with specified exceptions)
- History of organ or hematopoietic stem cell transplantation
- Use of immunosuppressive drugs within 4 weeks prior to tissue sampling or planned use during study (with specified exceptions)
- Receipt of systemic anti-tumor therapy within 4 weeks prior to pre-treatment or planned participation in other trials
- Presence of active infections including HIV, active hepatitis B or C, or active tuberculosis requiring treatment
- Recent vaccination with COVID-19 vaccine within 4 weeks or live vaccines within 3 months
- Major surgery or significant trauma within 4 weeks prior to screening or required elective surgery during study
- Surgical complications or delayed healing increasing treatment risk
- Another primary malignancy within 5 years except certain skin cancers
- Severe respiratory diseases such as interstitial lung disease or COPD
- Gastrointestinal bleeding requiring surgery, intestinal ischemia, or perforation
- Known meninges metastasis or uncontrolled central nervous system metastases
- Previous receipt of similar cell therapy products
- Pregnancy or lactation
- Mental illness, substance abuse, or other conditions deemed unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
W
Wenna Liu
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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