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New treatment option for B2 Thymoma
Official title Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
ClinicalTrials.gov ID: NCT07598955
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b2 thymoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Tumor antigen positivity for at least one of the following by central laboratory assessment: CD30, CD5, or mesothelin. Cohort assignment is based on...
- Measurable disease per RECIST v1.1 (or evaluable disease if measurable disease is not feasible; to be specified).
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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)...
- Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception.
- Ability to understand and sign informed consent.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.