Target-Selected CAR-NK Cells for B2 Thymoma or Thymic Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-indication, open-label Phase 1/2 study using off-the-shelf cord blood–derived NK cells engineered to express a single-target CAR (CD30, CD5, or mesothelin) with an IL-15 support element and an iCasp9 safety switch. Participants undergo centralized tumor antigen testing and are assigned to one of three parallel cohorts based on dominant antigen expression. The trial uses a 3+3 dose-escalation design in Phase 1 to identify the maximum tolerated or recommended dose, followed by a dose-expansion phase to further evaluate safety and preliminary anti-tumor activity. All cohorts receive a lymphodepleting regimen prior to CAR-NK infusion and will be monitored for persistence, immune activation, and potential biomarkers of response and resistance. Long-term follow-up includes monitoring for delayed adverse events and survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 (including a platinum-based regimen for thymic carcinoma when appropriate) or no standard curative option available.
* Tumor antigen positivity for at least one of the following by central laboratory assessment: CD30, CD5, or mesothelin. Cohort assignment is based on the dominant target (pre-specified algorithm) and feasibility of manufacturing/availability.
* Measurable disease per RECIST v1.1 (or evaluable disease if measurable disease is not feasible; to be specified).
* ECOG performance status 0-1 (0-2 may be permitted in expansion at investigator discretion).
* Adequate organ function: ANC ≥ 1.0 x 10\^9/L, platelets ≥ 75 x 10\^9/L, hemoglobin ≥ 8 g/dL (transfusions allowed), AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver involvement), total bilirubin ≤ 1.5 x ULN (except Gilbert's), creatinine clearance ≥ 50 mL/min.
* Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception.
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Active central nervous system involvement by malignancy requiring immediate therapy.
* Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 90 days or unresolved ≥Grade 2 toxicity from prior cellular therapy.
* Uncontrolled infection, including active tuberculosis, or uncontrolled hepatitis B or C infection; known uncontrolled HIV infection.
* Clinically significant autoimmune disease requiring systemic immunosuppression (e.g., \>10 mg/day prednisone equivalent) within 14 days of conditioning, except for stable endocrine replacement.
* Prior allogeneic hematopoietic stem cell transplant with active graft-versus-host disease or ongoing immunosuppression.
* Significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction), uncontrolled arrhythmia, or QTc prolongation felt to increase risk.
* Pregnancy or breastfeeding.
* Concurrent participation in another interventional trial with an investigational anticancer agent within 21 days (washout required).
* Any condition that, in the investigator's judgment, would interfere with safe participation or interpretation of results.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.