NCT07598955 Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
| NCT ID | NCT07598955 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Biotech |
| Condition | B2 Thymoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-03-02 with a primary completion date of 2027-06-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase 1/2 study evaluates the safety, tolerability, and preliminary efficacy of target-selected CAR-natural killer (CAR-NK) cells in adults with relapsed or refractory B2 thymoma or thymic carcinoma. Participants undergo centralized tumor antigen assessment (CD30, CD5, and mesothelin). Based on the dominant and clinically actionable antigen expression profile, each participant is assigned to one of three parallel cohorts (CD30-CAR-NK, CD5-CAR-NK, or mesothelin-CAR-NK). All cohorts use the same lymphodepleting conditioning regimen followed by CAR-NK infusion(s).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07598955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying B2 Thymoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07598955 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07598955 currently recruiting?
Yes, NCT07598955 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07598955 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07598955 clinical trial?
NCT07598955 is sponsored by Beijing Biotech. The trial plans to enroll 36 participants.