Actively Recruiting
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
Led by Chinese PLA General Hospital · Updated on 2023-08-28
10
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.
CONDITIONS
Official Title
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- ECOG performance status of 0 to 2 and life expectancy more than 3 months
- Diagnosed with locally advanced/metastatic solid tumors or relapsed/refractory lymphomas confirmed by histopathology or cytology
- Tumor tested positive for EphA2 expression (at least 20%) and TP53 mutation (R273H, R175H, R248Q, or R249S) within 6 months before screening
- No clinical response to standard frontline therapy or no standard therapy available for solid tumors; relapse after at least two lines of systemic therapy or refractory disease for lymphomas
- Patients who declined or lack access to standard therapy with documented reasons
- Previous treatment with anti-PD-1/PD-L1 or anti-CTLA4 antibodies allowed
- At least one measurable lesion at baseline per RECIST 1.1 or Lugano response criteria 2014
- Adequate organ function as defined by specific blood counts and liver/kidney function tests
- Willing to undergo excised or large-needle lymph node or tissue biopsy or provide tumor tissue blocks or slides
- Willing to complete all scheduled visits and assessments at the treatment institution
- Able to read, understand, and provide written informed consent
You will not qualify if you...
- Presence of TP53 germline mutations (R273H, R175H, R248Q, or R249S)
- Active central nervous system disease or recent severe CNS drug toxicity
- Prior organ allograft or allogeneic hematopoietic stem cell transplantation
- Active uncontrolled infections including viral, bacterial, or fungal
- Positive for HIV or AIDS
- Active hepatitis B or C infection
- History or risk of autoimmune disease with recent immunosuppressive medication or corticosteroids exceeding 10 mg/day prednisone equivalent
- Major trauma or surgery within 4 weeks before enrollment
- Previous treatment targeting TP53 mutant or EphA2
- Systemic chemotherapy or other interventions within 2 weeks before vaccination
- Participation in or withdrawal from other trials within 4 weeks
- Serious medical or psychiatric conditions limiting study compliance
- Vaccination within 30 days before enrollment
- Pregnant, lactating, or breastfeeding females
- Other reasons deemed unsuitable for trial participation by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China, 100853
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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