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Malignant Pleural MesotheliomasPhase 1/2DUAL-MESO-NKNCT07510815

Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma

A Phase 1/2 study testing EB-MF-CAR-NK-01, Fludarabine and Cyclophosphamide in people with Malignant Pleural Mesotheliomas, run by Beijing Biotech at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This example study evaluates locoregional allogeneic dual-target mesothelin/FAP CAR-NK cells in adults with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma. Eligible participants must have central confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Pleural Mesotheliomas
What is being tested?
EB-MF-CAR-NK-01, Fludarabine and Cyclophosphamide
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 malignant pleural mesothelioma or malignant peritoneal mesothelioma; unresectable, recurrent, metastatic, or refractory disease.
  • Prior receipt of at least one standard systemic regimen for mesothelioma, or documented ineligibility, intolerance, or refusal of standard therapy considered reasonable by the investigator.
  • Central biomarker confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma at protocol-defined thresholds.
  • At least one measurable or evaluable lesion by cohort-appropriate imaging criteria.
  • ECOG performance status 0 to 1.
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  • Adequate bone marrow, renal, hepatic, coagulation, cardiac, and pulmonary function to undergo lymphodepletion and locoregional cell infusion.
  • Safe procedural access for intrapleural or intraperitoneal administration, as applicable.
  • Recovery to Grade 1 or better from prior anticancer therapy toxicities, except alopecia, stable neuropathy, or controlled endocrine replacement.
  • Life expectancy of at least 12 weeks.
  • Negative pregnancy test for participants of childbearing potential and agreement to use protocoldefined contraception.
  • Ability to understand and sign informed consent

Who cannot join

  • Active or untreated CNS metastases, leptomeningeal disease, or uncontrolled seizures.
  • Uncontrolled bacterial, fungal, viral, or mycobacterial infection, including empyema, active pleural space infection, peritonitis, or uncontrolled HBV, HCV, or HIV infection.
  • Autoimmune disease requiring systemic immunosuppression within 14 days before lymphodepletion, or prednisone equivalent greater than 10 mg/day.
  • Clinically significant cardiovascular disease, uncontrolled arrhythmia, unstable angina, recent myocardial infarction, or other condition judged to increase infusion risk.
  • Severe interstitial lung disease, baseline oxygen requirement, or other pulmonary compromise making pleural therapy unsafe.
  • Bowel perforation risk, uncontrolled bowel obstruction, uncontrolled ascites, or any abdominal condition that makes intraperitoneal infusion unsafe in the peritoneal cohort.
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  • Prior gene-modified cell therapy directed against MSLN or FAP within the protocol washout period, or active graft-versus-host disease after prior transplant.
  • Need for concurrent systemic anticancer therapy other than protocol-permitted supportive care.
  • Pregnancy or breastfeeding.
  • Any medical, psychiatric, social, or logistical condition that, in the investigator's judgment, could compromise safety, compliance, or interpretability of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seni S Lu, Phd contact

+86 13076790030

Seni-Lu@beijing-biotech.com

China1 site, 1 recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Open-Label, Nonrandomized, Biomarker-Guided Study of Locoregional Allogeneic Dual-Target Mesothelin (MSLN) / Fibroblast Activation Protein (FAP) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Recurrent, or Refractory Pleural or Peritoneal Mesothelioma

This example study evaluates locoregional allogeneic dual-target mesothelin/FAP CAR-NK cells in adults with unresectable, recurrent, or refractory pleural or peritoneal mesothelioma.

Eligible participants must have central confirmation of MSLN-positive tumor cells and FAP-positive tumorassociated stroma. The phase 1 portion defines the recommended phase 2 dose and schedule, and the phase 2 expansion explores preliminary antitumor activity, persistence, and biomarker response in pleural and peritoneal disease cohorts.

Read the detailed description

Mesothelioma remains a difficult serosal malignancy with limited curative options in recurrent or refractory disease. Mesothelin (MSLN) is a well-established tumor-associated antigen in malignant pleural mesothelioma and other serosal tumors, while fibroblast activation protein (FAP) is relevant in the dense, immunosuppressive stromal compartment that can limit immune-cell trafficking and persistence. For this example, MSLN is retained as the anchor target and FAP is selected as the preferred second target after assessment.

Screening includes central pathology review using archival or fresh tissue and, where available, complementary liquid-biopsy profiling. Participants enter this dual-target study only if both MSLN and FAP meet pre-specified positivity thresholds. If only one actionable target is confirmed, the participant should be considered for a companion single-target protocol rather than this draft dual target protocol.

The study is designed as an open-label, biomarker-guided phase 1/2 trial with two nonrandomized parallel cohorts defined by disease site: pleural mesothelioma and peritoneal mesothelioma.

Part 1uses staggered locoregional dose escalation to determine the recommended phase 2 dose and schedule.

Part 2 expands each cohort at the selected dose. Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide before CAR-NK infusion. Delivery is intrapleural for pleural mesothelioma and intraperitoneal for peritoneal mesothelioma. A repeat infusion may be permitted between Day 21 and Day 35 if there is no dose-limiting toxicity and no radiographic progression.

Key objectives are to characterize safety, define the recommended dose and schedule, estimate preliminary antitumor activity, and study pharmacodynamic effects including CAR-NK persistence in blood and serosal fluid, changes in soluble mesothelin-related peptide (SMRP), ctDNA dynamics, and cytokine modulation within pleural or peritoneal compartments.

Being tested
EB-MF-CAR-NK-01, Fludarabine, Cyclophosphamide
Keywords
Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma, MSLN, FAP, Dual-Target CAR-NK, Locoregional Cell Therapy, Solid Tumor Immunotherapy
Medical subject headings
Mesothelioma, Malignant, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EB-MF-CAR-NK-01Biological

    Also called Mesothelin/FAP Dual-Target CAR-NK Cells

    Example investigational product: donor-derived allogeneic NK cells engineered to recognize both MSLN-positive tumor cells and FAPpositive stromal elements, manufactured under GMP

  • FludarabineDrug

    Also called Flu

    Lymphodepleting chemotherapy administered before CAR-NK infusion

  • CyclophosphamideDrug

    Also called Cy

    Lymphodepleting chemotherapy administered before CAR-NK infusion.

Study groups in NCT07510815
Study groupRoleWhat they receive
Pleural Mesothelioma CohortExperimentalParticipants with malignant pleural mesothelioma receive lymphodepleting chemotherapy followed by locoregional intrapleural infusion of the dual-target allogeneic CAR-NK product.
Receives: Biological: EB-MF-CAR-NK-01; Drug: Fludarabine; Drug: Cyclophosphamide
Peritoneal Mesothelioma CohortExperimentalParticipants with malignant peritoneal mesothelioma receive the same conditioning backbone and product platform, but the CAR-NK cells are delivered by locoregional intraperitoneal administration.
Receives: Biological: EB-MF-CAR-NK-01; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) after first CAR-NK infusion

    Measured: 28 days

  2. ncidence and severity of treatment-emergent adverse events (TEAEs)

    ncidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, pleuritis/peritonitis, infusion reactions, and on-target/off-tumor toxicities graded by CTCAE v5.0 and ASTCT crit

    Measured: 12 months

  3. Determination of recommended phase 2 dose and schedule (RP2D/RP2S)

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate (ORR) by modified RECIST for the pleural cohort and RECIST 1.1 for the peritoneal cohort

    Measured: 12 months

  2. Disease control rate (DCR) at 12 weeks

    Measured: 12 weeks

  3. Duration of response (DOR)

    Measured: 24 months

  4. Progression-free survival (PFS)

    Measured: 24 months

  5. Overall survival (OS)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start2 Mar 2026
  3. Primary completion14 Mar 2027 (estimated)
  4. Study completion17 Apr 2028 (estimated)

Resources

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
Two open-label, nonrandomized locoregional cohorts run in parallel according to disease site (pleural vs peritoneal mesothelioma). Part 1 uses staggered dose escalation in both cohorts to identify the recommended phase 2 dose and schedule. Part 2 expands each cohort separately at the selected dose. Assignment is based on disease anatomy and biomarker positivity, not randomization.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510815
Sponsor's protocol ID
EB-CARNK-CRC-102
Acronym
DUAL-MESO-NK
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EB-MF-CAR-NK-01, Fludarabine and Cyclophosphamide in people with Malignant Pleural Mesotheliomas, 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 12 inclusion and 10 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 6 Apr 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) after first CAR-NK infusion (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510815.

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 6 Apr 2026.

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