Actively Recruiting
A Phase 1/2, Open-Label Study of Allogeneic CAR-NK Cells Targeting CD30, CD5, or Mesothelin in Adults With Relapsed or Refractory B2 Thymoma or Thymic Carcinoma
Led by Beijing Biotech · Updated on 2026-05-20
36
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early effectiveness of target-selected CAR-natural killer (CAR-NK) cell therapies in adults with relapsed or refractory B2 thymoma or thymic carcinoma. This Phase 1/2 study assigns participants to one of three groups based on tumor antigen expression (CD30, CD5, or mesothelin) to receive a matching CAR-NK treatment. The study explores a new approach using genetically modified immune cells to target these cancers. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days before getting their assigned CAR-NK cell infusion on Day 0. In Phase 1, dose levels are gradually increased to find the maximum tolerated or recommended dose. Phase 2 expands enrollment to further assess safety and preliminary antitumor activity. A second CAR-NK infusion on Day 7 may be given if no severe side effects occur and product is available. During the study, participants undergo tumor antigen testing, blood and tumor sampling to monitor CAR-NK cell persistence, immune responses, and biomarkers. Safety is closely followed, especially for dose-limiting toxicities in the first 28 days after infusion. Long-term follow-up will monitor delayed side effects and survival. The full participation period includes screening, treatment, and extended observation as guided by gene therapy protocols.
CONDITIONS
Brief Title
Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent
- Histologically confirmed B2 thymoma or thymic carcinoma that is unresectable, metastatic, or recurrent
- Relapsed or refractory after at least 1 prior systemic therapy or no standard curative option available
- Tumor antigen positive for CD30, CD5, or mesothelin by central laboratory assessment
- Measurable or evaluable disease per RECIST v1.1
- ECOG performance status 0-1 (0-2 may be permitted in expansion at investigator discretion)
- Adequate organ function including ANC 2 1.0 x 10^9/L, platelets 2 75 x 10^9/L, hemoglobin 2 8 g/dL, AST/ALT 4 3 x ULN (4 5 x ULN with liver involvement), total bilirubin 4 1.5 x ULN (except Gilbert's), creatinine clearance 2 50 mL/min
- Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Active central nervous system involvement by malignancy requiring immediate therapy
- Prior gene-modified cellular therapy within 90 days or unresolved grade 2 or higher toxicity from prior cellular therapy
- Uncontrolled infection including active tuberculosis, hepatitis B or C, or known uncontrolled HIV infection
- Clinically significant autoimmune disease requiring systemic immunosuppression within 14 days of conditioning except stable endocrine replacement
- Prior allogeneic hematopoietic stem cell transplant with active graft-versus-host disease or ongoing immunosuppression
- Significant cardiovascular disease such as NYHA class III/IV heart failure, recent myocardial infarction, uncontrolled arrhythmia, or QTc prolongation
- Pregnancy or breastfeeding
- Concurrent participation in another interventional trial with an investigational anticancer agent within 21 days
- Any condition interfering with safe participation or result interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to CAR-NK cell infusion.
Daily visits for 3 days
Duration - Up to 28 days for initial assessment, with possible second infusion on Day 7
Participants receive an infusion of allogeneic CAR-NK cells targeting CD30, CD5, or mesothelin. A second infusion on Day 7 may be given if no severe toxicity occurs and product is available.
1 infusion visit on Day 0 and possibly 1 additional infusion visit on Day 7
Duration - Up to 12 months or longer
Participants are monitored for delayed adverse events, survival, and long-term effects following CAR-NK cell therapy.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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