AzTrials
AzTrials

Clear Cell Renal Cell CarcinomaEarly Phase 1CM-BA-9NCT07865832

A Study of CA9-Targeted CAR Macrophage Therapy in Advanced Clear Cell Renal Cell Carcinoma

A Early Phase 1 study testing CM-BA-9 in people with Clear Cell Renal Cell Carcinoma, run by Liangyou Gu at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Clear cell renal cell carcinoma is the most common type of kidney cancer. Although new treatments such as immune checkpoint inhibitors and targeted therapies have improved outcomes for many patients, some patients with advanced disease may still experience disease progression and require new treatment approaches. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
CM-BA-9
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
Nov 2026to Sep 2029
Phase
Early Phase 1
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

  • 1. Male or female participants aged 18 to 75 years.
  • 2. Histologically confirmed clear cell renal cell carcinoma (ccRCC).
  • 3. Unresectable locally advanced or metastatic renal cell carcinoma.
  • 4. Participants with advanced disease who require later-line systemic treatment following progression on prior standard anticancer therapy, as determined by the investigator.
  • 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  • 6. At least one tumor lesion suitable for ultrasound-guided intratumoral injection, including a primary renal tumor, residual renal lesion, or locoregionally recurrent lesion in the renal region.
Show all 17Show fewer
  • 7. Evidence of CA9 expression in the lesion intended for injection or a representative tumor lesion, as determined according to protocol-defined criteria.
  • 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • 9. Life expectancy of at least 12 weeks.
  • 10. Adequate bone marrow function, defined as an absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, and hemoglobin (Hb) ≥90 g/L, and meeting the requirements for peripheral blood mononuclear cell (PBMC) collection.
  • 11. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × the upper limit of normal (ULN), or ≤5 × ULN in the presence of liver metastases, and total bilirubin ≤1.5 × ULN.
  • 12. Adequate renal function, defined as estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m² or serum creatinine ≤1.5 × ULN.
  • 13. Adequate coagulation function for tumor puncture and intratumoral injection, defined as international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
  • 14. Considered by the investigator to be able to tolerate filgrastim mobilization, PBMC collection, and subsequent cellular therapy procedures.
  • 15. Screening for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and syphilis meeting protocol-defined requirements.
  • 16. Considered by the investigator to be able to tolerate ultrasound-guided tumor puncture and intratumoral injection.
  • 17. Voluntary participation in the study and provision of written informed consent before initiation of any study-related procedures.

Who cannot join

  • 1. Life expectancy of less than 3 months.
  • 2. History of or concurrent active malignancy, except for cervical carcinoma in situ that has been cured or remained recurrence-free for at least 3 years, noninvasive basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ after curative resection, or localized prostate cancer with no evidence of recurrence after definitive treatment.
  • 3. Prior treatment with CA9-targeted cellular therapy, or other CA9-targeted therapy that, in the investigator's judgment, may interfere with the safety or efficacy assessments of this study.
  • 4. Prior treatment with CAR-T, CAR-NK, CAR-M, or other genetically engineered cellular therapy.
  • 5. History of clinically significant central nervous system disease or dysfunction, including but not limited to stroke, intracranial hemorrhage, epilepsy, dementia, cerebellar disease, or aphasia; or active central nervous system metastases with associated symptoms.
  • 6. History of solid organ transplantation (e.g., heart, lung, liver, or kidney) or hematopoietic stem cell/bone marrow transplantation.
Show all 23Show fewer
  • 7. Myocardial infarction, percutaneous coronary intervention, coronary stent placement, unstable angina, or other clinically significant severe cardiovascular disease within 12 months before screening.
  • 8. Toxicities related to prior anticancer therapy that have not recovered to Grade ≤1 according to CTCAE v5.0, except for alopecia, stable endocrine abnormalities, or other toxicities considered by the investigator not to pose a safety risk.
  • 9. Prior anticancer therapy for which the protocol-specified washout period has not been completed, or for which fewer than 5 half-lives of the respective treatment have elapsed before study treatment.
  • 10. Uncontrolled active bacterial, viral, fungal, or other pathogenic infection, or other infectious disease considered by the investigator to preclude participation in the study.
  • 11. Positive human immunodeficiency virus (HIV) antibody; untreated syphilis with positive Treponema pallidum antibody; hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA; or detectable hepatitis C virus (HCV) RNA. Participants whose infection can be adequately controlled with prophylactic or therapeutic medication, as determined by the investigator, may be eligible.
  • 12. Known active autoimmune disease requiring systemic treatment, or a history of severe autoimmune disease considered by the investigator to confer a high risk associated with study treatment.
  • 13. History of severe hypersensitivity to filgrastim, the cellular product, any medication used during the study, or any of their components.
  • 14. Pregnant or breastfeeding women; participants of childbearing potential and their partners who are unwilling to use effective contraception during the study.
  • 15. Participation in another interventional clinical study with receipt of investigational treatment within 3 months before signing informed consent, or planned participation in another clinical study during the study period.
  • 16. Depression, suicidal ideation, psychiatric disorder, or other psychological or psychiatric condition that may adversely affect study compliance or safety.
  • 17. Uncontrolled systemic inflammatory disease, a history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS), or a condition considered by the investigator to confer a high risk of cytokine storm.
  • 18. Clinically significant coagulation abnormality, bleeding tendency, or inability to discontinue anticoagulant or antiplatelet therapy, including but not limited to INR >1.5, APTT >1.5 × the upper limit of normal (ULN), or platelet count <75 × 10⁹/L.
  • 19. End-stage renal disease, dialysis dependence, or severe renal impairment considered by the investigator to preclude safe intratumoral injection.
  • 20. Unsuitability for ultrasound-guided intratumoral injection based on imaging assessment, including but not limited to inability to establish a safe puncture route, proximity of the target lesion to major blood vessels or vital organs, high bleeding risk, or a lesion location that cannot be safely accessed.
  • 21. Inability, as determined by the investigator, to tolerate filgrastim mobilization, PBMC collection, cell manufacturing, or subsequent cellular therapy procedures.
  • 22. Any disease, laboratory abnormality, or social circumstance that may interfere with safety or efficacy assessments or the participant's ability to complete the study.
  • 23. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Trial locations and contacts

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

Liangyou Gu contact

+86 010 6693 7166

guliangyouyd1@126.com

China1 site

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100853

    Liangyou Gu, +86 010 6693 7166, guliangyouyd1@126.com

    Liangyou Gu

Other trials in China

About this study

Official title: An Exploratory Clinical Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of Intratumoral Delivery of CA9-Targeted Chimeric Antigen Receptor Macrophage Therapy in Patients With Unresectable or Metastatic Clear Cell Renal Cell Carcinoma

Clear cell renal cell carcinoma is the most common type of kidney cancer. Although new treatments such as immune checkpoint inhibitors and targeted therapies have improved outcomes for many patients, some patients with advanced disease may still experience disease progression and require new treatment approaches. This study evaluates the safety, feasibility, and preliminary effectiveness of a novel cell therapy called CA9-targeted chimeric antigen receptor macrophage (CAR-M) therapy in patients with unresectable or metastatic clear cell renal cell carcinoma. CA9 is a protein that is highly expressed on many clear cell renal cell carcinoma cells and can be recognized by CAR-M cells. In this study, patients will receive a local injection of CM-BA-9, a CA9-targeted CAR-M cell product, into selected tumor lesions. The study will primarily assess treatment safety and tolerability, while also exploring whether this therapy can control tumor growth. The information collected in this study may help researchers better understand the potential role of CAR-M therapy in the treatment of advanced clear cell renal cell carcinoma.

Read the detailed description

Clear cell renal cell carcinoma (ccRCC) represents the predominant histological subtype of renal cell carcinoma and is characterized by frequent alterations in the tumor microenvironment, including immune suppression and abnormal angiogenesis. Despite advances in immune checkpoint inhibitors and targeted therapies, patients with unresectable or metastatic ccRCC may develop resistance and have limited treatment options. Carbonic anhydrase IX (CA9) is a tumor-associated antigen highly expressed in most ccRCC tumors with limited expression in normal tissues, making it a potential therapeutic target. Chimeric antigen receptor macrophage (CAR-M) therapy is an emerging cellular immunotherapy strategy designed to enhance macrophage-mediated recognition and elimination of tumor cells. This exploratory clinical study is designed to evaluate the safety, feasibility, and preliminary efficacy of intratumoral delivery of CM-BA-9, a CA9-targeted CAR-M cell therapy product, in patients with unresectable or metastatic ccRCC. The study will evaluate treatment-related adverse events, dose-limiting toxicities, feasibility of product administration, and preliminary antitumor activity. The findings from this study will provide preliminary clinical evidence regarding the safety profile and potential therapeutic value of CA9-targeted CAR-M therapy and may support further investigation of cellular immunotherapy approaches for advanced ccRCC.

Being tested
CM-BA-9
Keywords
CA9, Chimeric Antigen Receptor Macrophage, CAR-M, Cell Therapy, CM-BA-9, Advanced Clear Cell Renal Cell Carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • CM-BA-9Biological

    CM-BA-9 is an autologous CA9-targeted chimeric antigen receptor macrophage (CAR-M) cell product. After peripheral blood mononuclear cell collection and manufacturing, CM-BA-9 will be administered as a single ultrasound-guided intratumoral injection.

Study groups in NCT07865832
Study groupRoleWhat they receive
CM-BA-9 Sequential Dose Exploration CohortExperimentalParticipants will receive a single ultrasound-guided intratumoral injection of CM-BA-9. After completion of protocol-defined safety monitoring, subsequent anticancer therapies, including targeted therapy or immune checkpoint inhibitor-based therapy, may be administered according to investigator assessment.
Receives: Biological: CM-BA-9

What is being measured

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

  1. Safety and tolerability of CM-BA-9

    Safety and tolerability will be assessed based on the incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and intratumoral injection-related complications. DLTs will be assessed during the 28-day DLT evaluation period. Safety events will be evaluated throughout the study according to the protocol-defined criteria.

    Measured: From CM-BA-9 administration through 52 weeks after treatment

  2. Feasibility of CM-BA-9 manufacturing and administration

    Feasibility will be assessed based on successful completion of peripheral blood mononuclear cell (PBMC) collection, cell manufacturing and product release, preparation for administration, intratumoral administration, and the overall treatment process according to the study protocol.

    Measured: Within 3 weeks before CM-BA-9 administration

Secondary outcomes (6)

  1. Objective response rate (ORR)

    The proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), as assessed according to RECIST v1.1.

    Measured: Within 52 weeks after CM-BA-9 administration

  2. Disease control rate (DCR)

    The proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST v1.1.

    Measured: Within 52 weeks after CM-BA-9 administration

  3. Duration of response (DoR)

    Duration of response will be assessed among participants achieving CR or PR and defined as the time from the first documented objective response to disease progression or death, whichever occurs first.

    Measured: From first documented CR or PR to disease progression or death, up to 52 weeks after CM-BA-9 administration

  4. Progression-free survival (PFS)

    Progression-free survival will be defined as the time from CM-BA-9 administration to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: From CM-BA-9 administration to disease progression or death, up to 52 weeks

  5. Overall survival (OS)

    Overall survival will be defined as the time from CM-BA-9 administration to death from any cause.

    Measured: From CM-BA-9 administration to death from any cause, up to 52 weeks

  6. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

    Changes in Eastern Cooperative Oncology Group (ECOG) performance status and clinical symptoms after CM-BA-9 administration will be evaluated during follow-up. ECOG performance status will be assessed using the ECOG Performance Status Scale, ranging from 0 to 5, with higher scores indicating greater functional impairment.

    Measured: Baseline and follow-up visits through 52 weeks after CM-BA-9 administration

Timeline

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

  1. First posted8 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, open-label, exploratory clinical study evaluating the safety, feasibility, and preliminary efficacy of CM-BA-9 in patients with unresectable or metastatic clear cell renal cell carcinoma. The study uses a fixed-sample-size, sequential dose-exploration design.
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865832
Sponsor's protocol ID
CM-BA-9-001
Acronym
CM-BA-9
Status last verified
Oct 2026
First submitted
30 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be shared.

Publications

  • Jing W, Han M, Wang G, Kong Z, Zhao X, Fu Z, Jiang X, Shi C, Chen C, Zhang J, Zheng Z, Gao J, Sun W, Tang C, Yang Z, Wang Y, Liu Y, Zhao K, Zhu D, Shi B, Jiang X. An in situ engineered chimeric IL-2 receptor potentiates the tumoricidal activity of proinflammatory CAR macrophages in renal cell carcinoma. Nat Cancer. 2025 May;6(5):838-853. doi: 10.1038/s43018-025-00950-1. Epub 2025 Apr 29.

    PubMed 40301655

  • Duan Z, Li Z, Wang Z, Chen C, Luo Y. Chimeric antigen receptor macrophages activated through TLR4 or IFN-gamma receptors suppress breast cancer growth by targeting VEGFR2. Cancer Immunol Immunother. 2023 Oct;72(10):3243-3257. doi: 10.1007/s00262-023-03490-8. Epub 2023 Jul 12.

    PubMed 37438548

  • Cai J, Liu Z, Chen S, Zhang J, Li H, Wang X, Yang F, Wang S, Li X, Li Y, Chen K, Wang J, Sun M, Qiu M. Engineered circular RNA-based DLL3-targeted CAR-T therapy for small cell lung cancer. Exp Hematol Oncol. 2025 Mar 12;14(1):35. doi: 10.1186/s40164-025-00625-8.

    PubMed 40075480

  • Hu Q, Zhao H, Zhou K, Tian X, Wang Q, Hua X, Zhang X. Scarless circular mRNA-based CAR-T cell therapy elicits superior antitumor efficacy. Signal Transduct Target Ther. 2025 Dec 23;10(1):411. doi: 10.1038/s41392-025-02512-4.

    PubMed 41430032

  • Reiss KA, Angelos MG, Dees EC, Yuan Y, Ueno NT, Pohlmann PR, Johnson ML, Chao J, Shestova O, Serody JS, Schmierer M, Kremp M, Ball M, Qureshi R, Schott BH, Sonawane P, DeLong SC, Christiano M, Swaby RF, Abramson S, Locke K, Barton D, Kennedy E, Gill S, Cushing D, Klichinsky M, Condamine T, Abdou Y. CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial. Nat Med. 2025 Apr;31(4):1171-1182. doi: 10.1038/s41591-025-03495-z. Epub 2025 Feb 7.

    PubMed 39920391

  • Klichinsky M, Ruella M, Shestova O, Lu XM, Best A, Zeeman M, Schmierer M, Gabrusiewicz K, Anderson NR, Petty NE, Cummins KD, Shen F, Shan X, Veliz K, Blouch K, Yashiro-Ohtani Y, Kenderian SS, Kim MY, O'Connor RS, Wallace SR, Kozlowski MS, Marchione DM, Shestov M, Garcia BA, June CH, Gill S. Human chimeric antigen receptor macrophages for cancer immunotherapy. Nat Biotechnol. 2020 Aug;38(8):947-953. doi: 10.1038/s41587-020-0462-y. Epub 2020 Mar 23.

    PubMed 32361713

  • Mueller KP, Grenier JM, Weber EW. CAR T cell persistence in cancer. Trends Cancer. 2025 Oct;11(10):1005-1018. doi: 10.1016/j.trecan.2025.08.014. Epub 2025 Sep 18.

    PubMed 40973578

  • Shuch B, Pantuck AJ, Bernhard JC, Morris MA, Master V, Scott AM, van Praet C, Bailly C, Onal B, Aksoy T, Merkx R, Schuster DM, Lee ST, Pandit-Taskar N, Fan AC, Allman P, Schmidt K, Tauchmanova L, Wheatcroft M, Behrenbruch C, Hayward CRW, Mulders P. [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Oct;25(10):1277-1287. doi: 10.1016/S1470-2045(24)00402-9. Epub 2024 Sep 10.

    PubMed 39270701

  • Powles T, Albiges L, Bex A, Comperat E, Grunwald V, Kanesvaran R, Kitamura H, McKay R, Porta C, Procopio G, Schmidinger M, Suarez C, Teoh J, de Velasco G, Young M, Gillessen S; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Renal cell carcinoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024 Aug;35(8):692-706. doi: 10.1016/j.annonc.2024.05.537. Epub 2024 May 22. No abstract available.

    PubMed 38788900

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CM-BA-9 in people with Clear Cell Renal Cell Carcinoma, run by Liangyou Gu 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 17 inclusion and 23 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: opening soon, as of the sponsor's last update on 8 Oct 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Liangyou Gu (+86 010 6693 7166, guliangyouyd1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of CM-BA-9 (time frame: From CM-BA-9 administration through 52 weeks after treatment). 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?

On the ClinicalTrials.gov record for NCT07865832, which also lists 9 linked publications.

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 8 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in