B2 ThymomaPhase 1/2SELECT-NK-THYMNCT07598955
Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and EB-CAR30-NK in people with B2 Thymoma and Thymic Carcinoma, run by Beijing Biotech at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B2 Thymoma, Thymic Carcinoma
- What is being tested?
- Cyclophosphamide, Fludarabine and EB-CAR30-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
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).
Read the detailed description
This is a first-in-indication, open-label, non-randomized, multi-center Phase 1/2 study with biomarker-driven cohort assignment. Phase 1 (dose escalation): Within each target cohort, a standard 3+3 dose-escalation design evaluates up to three dose levels of the assigned CAR-NK product to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Dose-limiting toxicities (DLTs) are assessed from Day 0 through Day 28 after the first CAR-NK infusion. Phase 2 (dose expansion): After an RP2D is identified in a cohort, an expansion stage enrolls additional participants in that cohort to further characterize safety and estimate preliminary antitumor activity. CAR-NK product: Off-the-shelf, allogeneic cord blood-derived NK cells are genetically modified to express a single-target CAR (anti-CD30, anti-CD5, or anti-mesothelin). The construct includes an IL-15 support element to enhance persistence and an inducible caspase-9 (iCasp9) safety switch for rapid elimination of CAR-NK cells if clinically indicated. Correlative studies: Serial blood and (when feasible) tumor sampling will evaluate CAR-NK persistence, immune activation markers, cytokines, tumor antigen modulation, and exploratory biomarkers of response and resistance. Long-term follow-up: Participants will be followed for delayed adverse events and survival; participants receiving gene-modified cells will also be invited to long-term follow-up consistent with applicable gene therapy guidance.
- Conditions
- B2 Thymoma, Thymic Carcinoma
- Being tested
- Cyclophosphamide, Fludarabine, EB-CAR30-NK, EB-CAR5-NK, EB-CARMSLN-NK
- Keywords
- CAR-NK, Natural killer cells, Adoptive cell therapy, Thymic epithelial tumor, CD30, CD5, Mesothelin, Biomarker-guided, Solid tumor immunotherapy
- Medical subject headings
- Thymoma, Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
lymphodepletion
FludarabineDrug
lymphodepletion
EB-CAR30-NKBiological
CD30-targeted allogeneic CAR-NK cells
EB-CAR5-NKBiological
CD5-targeted allogeneic CAR-NK cells
EB-CARMSLN-NKBiological
Mesothelin-targeted allogeneic CAR-NK cells
Rimiducid (AP1903)Drug
ctivate the iCasp9 safety switch if clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: CD30-CAR-NK | Experimental | Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to
-3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: EB-CAR30-NK; Biological: EB-CAR5-NK; Biological: EB-CARMSLN-NK; Drug: Rimiducid (AP1903) |
| Cohort B: CD5-CAR-NK | Experimental | Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to
-3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: EB-CAR30-NK; Biological: EB-CAR5-NK; Biological: EB-CARMSLN-NK; Drug: Rimiducid (AP1903) |
| Cohort C: Mesothelin-CAR-NK | Experimental | Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to
-3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: EB-CAR30-NK; Biological: EB-CAR5-NK; Biological: EB-CARMSLN-NK; Drug: Rimiducid (AP1903) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
DLTs as defined in protocol, assessed during the DLT window after the first CAR-NK infusion. Includes severe infusion-related toxicity, Grade >=3 organ toxicity attributable to CAR-NK cells, severe CRS or neurotoxicity, and treatment-related death.
Measured: 28 Days
Recommended Phase 2 Dose
Determined separately for each cohort based on DLTs, overall safety, and pharmacodynamic data
Measured: 28 Days
Secondary outcomes (2)
Objective Response Rate
Proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 (or modified criteria appropriate for thymic tumors) in each cohort.
Measured: 12 months
Disease Control Rate
Proportion of participants with CR, PR, or stable disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start2 Mar 2026
- Primary completion14 Jun 2027 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B2 ThymomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three CAR-NK target cohorts based on centralized tumor antigen expression testing (CD30, CD5, mesothelin). Each cohort uses a Phase 1 dose-escalation stage followed by a Phase 2 expansion stage.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598955
- Sponsor's protocol ID
- EB-CARNK-THYM-009
- Acronym
- SELECT-NK-THYM
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT07598955
- Acronym / sponsor ID
- SELECT-NK-THYM / EB-CARNK-THYM-009
- Conditions
- B2 Thymoma, Thymic Carcinoma
- Keywords
- CAR-NK, Natural killer cells, Adoptive cell therapy, Thymic epithelial tumor, CD30, CD5, Mesothelin, Biomarker-guided
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a first-in-indication, open-label, non-randomized, multi-center Phase 1/2 study with biomarker-driven cohort assignment. Phase 1 (dose escalation): Within each target cohort, a standard 3+3 dose-escalation design evaluates up to three dose levels of the assigned CAR-NK product to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Dose-limiting toxicities (DLTs) are assessed from Day 0 through Day 28 after the first CAR-NK infusion. Phase 2 (dose expansion): After an RP2D is identified in a cohort, an expansion stage enrolls additional participants in that cohort to further characterize safety and estimate preliminary antitumor activity. CAR-NK product: Off-the-shelf, allogeneic cord blood-derived NK cells are genetically modified to express a single-target CAR (anti-CD30, anti-CD5, or anti-mesothelin). The construct includes an IL-15 support element to enhance persistence and an inducible caspase-9 (iCasp9) safety switch for rapid elimination of CAR-NK cells if clinically indicated. Correlative studies: Serial blood and (when feasible) tumor sampling will evaluate CAR-NK persistence, immune activation markers, cytokines, tumor antigen modulation, and exploratory biomarkers of response and resistance. Long-term follow-up: Participants will be followed for delayed adverse events and survival; participants receiving gene-modified cells will also be invited to long-term follow-up consistent with applicable gene therapy guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to one of three CAR-NK target cohorts based on centralized tumor antigen expression testing (CD30, CD5, mesothelin). Each cohort uses a Phase 1 dose-escalation stage followed by a Phase 2 expansion stage.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: CD30-CAR-NK | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: EB-CAR30-NK, Biological: EB-CAR5-NK, Biological: EB-CARMSLN-NK, Drug: Rimiducid (AP1903)Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
| Cohort B: CD5-CAR-NK | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: EB-CAR30-NK, Biological: EB-CAR5-NK, Biological: EB-CARMSLN-NK, Drug: Rimiducid (AP1903)Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
| Cohort C: Mesothelin-CAR-NK | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: EB-CAR30-NK, Biological: EB-CAR5-NK, Biological: EB-CARMSLN-NK, Drug: Rimiducid (AP1903)Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamidelymphodepletion | Drug | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
| Fludarabinelymphodepletion | Drug | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
| EB-CAR30-NKCD30-targeted allogeneic CAR-NK cells | Biological | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
| EB-CAR5-NKCD5-targeted allogeneic CAR-NK cells | Biological | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
| EB-CARMSLN-NKMesothelin-targeted allogeneic CAR-NK cells | Biological | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
| Rimiducid (AP1903)ctivate the iCasp9 safety switch if clinically indicated | Drug | Cohort A: CD30-CAR-NK, Cohort B: CD5-CAR-NK, Cohort C: Mesothelin-CAR-NK |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 28 Days
DLTs as defined in protocol, assessed during the DLT window after the first CAR-NK infusion. Includes severe infusion-related toxicity, Grade >=3 organ toxicity attributable to CAR-NK cells, severe CRS or neurotoxicity, and treatment-related death.
Recommended Phase 2 Dose
Time frame: 28 Days
Determined separately for each cohort based on DLTs, overall safety, and pharmacodynamic data
2 secondary outcomes
Objective Response Rate
Time frame: 12 months
Disease Control Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and EB-CAR30-NK in people with B2 Thymoma and Thymic Carcinoma, run by Beijing Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.