Actively Recruiting
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors
Led by Chinese PLA General Hospital · Updated on 2023-07-17
30
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
CONDITIONS
Official Title
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- ECOG performance status of 2 or less and life expectancy over 3 months
- Histologically confirmed advanced or metastatic solid tumors with CD70 antigen expression of 30% or more
- At least one measurable tumor lesion at baseline by RECIST 1.1 criteria
- Availability of fresh or recent tumor samples within 6 months; willingness to undergo tumor rebiopsy during the study
- Adequate organ function including specific blood counts and liver and kidney function parameters
- Negative pregnancy test for women of childbearing age; agreement to use effective contraception during treatment and for one year after
- Ability to understand and sign informed consent form
You will not qualify if you...
- Use of corticosteroids over 10 mg prednisone daily or other immunosuppressive drugs within 14 days before enrollment
- Received chemotherapy, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives prior to enrollment
- Pregnant, lactating, or breastfeeding females
- Known HIV/AIDS or active hepatitis B or C infection
- History of allergy or intolerance to study drug components
- Prior organ transplant or allogeneic stem cell transplantation
- Major surgery or trauma within 28 days before enrollment or unresolved major side effects
- Known or active brain metastases or CNS involvement (except stable cases after radiotherapy)
- Previous or concurrent cancer within 5 years except certain treated cancers
- Serious underlying medical or psychiatric conditions that limit study compliance
- Vaccination within 30 days before enrollment
- Previous treatment with CD70-CAR T cell therapy
- Participation in other clinical trials or withdrawal within 4 weeks
- Other reasons judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China
Beijing, Iotherapeutic Department of Chinsese PLA Gereral Hospital, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
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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