Advanced or Metastatic Solid TumorsPhase 1/2PRISM-NKNCT07510828
PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors
A Phase 1/2 study testing EB-PT-CAR-NK-S, EB-PT-CAR-NK-D and Lymphodepleting chemotherapy in people with Advanced or Metastatic Solid Tumors, run by Beijing Biotech at 1 site in China.
Trial summary
This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- EB-PT-CAR-NK-S, EB-PT-CAR-NK-D and Lymphodepleting chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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 or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists.
- At least 1 measurable lesion per RECIST v1.1.
- Tumor antigen positivity documented by tissue biopsy and/or liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold.
- ECOG performance status 0-1.
- Adequate organ function (hematologic, renal, hepatic) as defined by protocol labs.
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- Ability to undergo lymphodepleting chemotherapy (if required) and receive IV cell infusion.
- Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.
- Willingness to provide baseline blood samples and, when feasible, tumor biopsy for biomarker analyses.
Who cannot join
- Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection.
- Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing).
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion.
- Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids.
- (Stable treated CNS disease may be allowed per protocol.)
- Current systemic immunosuppressive therapy (e.g., >10 mg/day prednisone equivalent) within a protocol-defined window prior to lymphodepletion.
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- Prior gene-modified cellular therapy within 3 months or any prior therapy that, in the investigator's judgment, would confound safety evaluation.
- Prior allogeneic hematopoietic stem cell transplant within 6 months, or active graft-versus-host disease.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's opinion, would interfere with study participation, compliance, 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 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and/or Tissue Biopsy) in Participants With Advanced Solid Tumors
This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells).
Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.
Read the detailed description
This example trial is designed to reflect common elements of early-phase CAR-NK studies in solid tumors, including dose escalation followed by expansion cohorts, open-label safety monitoring, and response assessment using standard radiologic criteria. Similar solid-tumor CAR-NK studies on ClinicalTrials.gov include trials targeting TROP2 (NCT06066424), NKG2D ligands (NCT03415100), and multi-target CAR-NK platforms that evaluate different antigens such as CLDN6, GPC3, mesothelin, or AXL (NCT05410717).
Antigen selection workflow (precision matching):
- Obtain tumor tissue biopsy (preferred) and/or blood for liquid biopsy at screening.
- Assess antigen expression using a prespecified panel (example panel: mesothelin, TROP2, HER2, MUC1, CLDN18.2, B7-H3/CD276, AXL, GPC3, CLDN6, EGFR).
- Assign participant to: (a) single-target cohort if one antigen meets the threshold; or (b) dual-target cohort if two antigens meet thresholds or if the investigator judges high risk of antigen heterogeneity.
- Select the matched cryopreserved allogeneic donor-derived CAR-NK product from a manufacturing bank and schedule treatment. Treatment overview: Participants receive lymphodepleting chemotherapy (e.g., fludarabine/cyclophosphamide) followed by one or more infusions of CAR-NK cells. Cytokine support (e.g., low-dose IL-2 or IL-15 agonist per institutional practice) may be given to promote CAR-NK persistence. Participants are monitored closely for cytokine release syndrome (CRS), neurotoxicity, infusion reactions, and other adverse events. Tumor imaging is performed at prespecified intervals during the first 6 months and then less frequently during follow-up.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- EB-PT-CAR-NK-S, EB-PT-CAR-NK-D, Lymphodepleting chemotherapy, Cytokine support
- Keywords
- allogeneic NK cells, solid tumor, CAR-NK, mesothelin, tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-PT-CAR-NK-SBiological
single-target CAR-NK cell infusion, IV
EB-PT-CAR-NK-DBiological
dual-target CAR-NK cell infusion, IV
Lymphodepleting chemotherapyDrug
fludarabine + cyclophosphamide
Cytokine supportDrug
low-dose IL-2 or IL-15 agonist
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Single-target precision-matched CAR-NK | Experimental | Participants with a single dominant tumor antigen (above a prespecified threshold) receive a matched single-target CAR-NK product manufactured from a healthy donor NK-cell source. Receives: Biological: EB-PT-CAR-NK-S; Biological: EB-PT-CAR-NK-D; Drug: Lymphodepleting chemotherapy; Drug: Cytokine support |
| Arm B: Dual-target precision-matched CAR-NK | Experimental | Participants with co-expression of two target antigens (or high antigen heterogeneity) receive a dual-target CAR-NK product designed to recognize both antigens (e.g., tandem CAR or bicistronic CAR configuration). Receives: Biological: EB-PT-CAR-NK-S; Biological: EB-PT-CAR-NK-D; Drug: Lymphodepleting chemotherapy; Drug: Cytokine support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose- limiting toxicities
Dose limiting toxicities refer to specific adverse events or side effects that prevent further dose escalation of an investigational drug or therapy in a clinical trial. DLTs are pre-defined based on severity, duration, and impact on patient safety, typically graded according to established criteria such as the Common Terminology Criteria for Adverse Events (CTCAE). Monitoring DLTs is a critical outcome measure in early-phase (Phase I/II) studies, as it helps determine the maximum tolerated dose (MTD) and guides safe dosing for subsequent trial phases.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start2 Mar 2026
- Primary completion14 Mar 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 Advanced or Metastatic Solid TumorsStudies 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
- Sequential
- Model description
- Biomarker-guided platform design. Participants are assigned based on tumor antigen profiling to receive either a single-target or dual-target CAR-NK product. Phase 1 uses a standard 3+3 dose-escalation design within each arm to identify the recommended Phase 2 dose (RP2D). Phase 2 includes target-specific expansion cohorts at the RP2D to estimate preliminary efficacy.
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07510828
- Sponsor's protocol ID
- ESBI2026-PRISM-NK-020
- Acronym
- PRISM-NK
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 6 Apr 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and/or Tissue Biopsy) in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07510828
- Acronym / sponsor ID
- PRISM-NK / ESBI2026-PRISM-NK-020
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- allogeneic NK cells, solid tumor, CAR-NK, mesothelin, tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 6 Apr 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, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells).
Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.
Detailed description
This example trial is designed to reflect common elements of early-phase CAR-NK studies in solid tumors, including dose escalation followed by expansion cohorts, open-label safety monitoring, and response assessment using standard radiologic criteria. Similar solid-tumor CAR-NK studies on ClinicalTrials.gov include trials targeting TROP2 (NCT06066424), NKG2D ligands (NCT03415100), and multi-target CAR-NK platforms that evaluate different antigens such as CLDN6, GPC3, mesothelin, or AXL (NCT05410717).
Antigen selection workflow (precision matching):
- Obtain tumor tissue biopsy (preferred) and/or blood for liquid biopsy at screening.
- Assess antigen expression using a prespecified panel (example panel: mesothelin, TROP2, HER2, MUC1, CLDN18.2, B7-H3/CD276, AXL, GPC3, CLDN6, EGFR).
- Assign participant to: (a) single-target cohort if one antigen meets the threshold; or (b) dual-target cohort if two antigens meet thresholds or if the investigator judges high risk of antigen heterogeneity.
- Select the matched cryopreserved allogeneic donor-derived CAR-NK product from a manufacturing bank and schedule treatment. Treatment overview: Participants receive lymphodepleting chemotherapy (e.g., fludarabine/cyclophosphamide) followed by one or more infusions of CAR-NK cells. Cytokine support (e.g., low-dose IL-2 or IL-15 agonist per institutional practice) may be given to promote CAR-NK persistence. Participants are monitored closely for cytokine release syndrome (CRS), neurotoxicity, infusion reactions, and other adverse events. Tumor imaging is performed at prespecified intervals during the first 6 months and then less frequently during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Biomarker-guided platform design. Participants are assigned based on tumor antigen profiling to receive either a single-target or dual-target CAR-NK product. Phase 1 uses a standard 3+3 dose-escalation design within each arm to identify the recommended Phase 2 dose (RP2D). Phase 2 includes target-specific expansion cohorts at the RP2D to estimate preliminary efficacy.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Single-target precision-matched CAR-NK | Experimental | Biological: EB-PT-CAR-NK-S, Biological: EB-PT-CAR-NK-D, Drug: Lymphodepleting chemotherapy, Drug: Cytokine supportParticipants with a single dominant tumor antigen (above a prespecified threshold) receive a matched single-target CAR-NK product manufactured from a healthy donor NK-cell source. |
| Arm B: Dual-target precision-matched CAR-NK | Experimental | Biological: EB-PT-CAR-NK-S, Biological: EB-PT-CAR-NK-D, Drug: Lymphodepleting chemotherapy, Drug: Cytokine supportParticipants with co-expression of two target antigens (or high antigen heterogeneity) receive a dual-target CAR-NK product designed to recognize both antigens (e.g., tandem CAR or bicistronic CAR configuration). |
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 or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists.
- At least 1 measurable lesion per RECIST v1.1.
- Tumor antigen positivity documented by tissue biopsy and/or liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold.
- ECOG performance status 0-1.
Key exclusion criteria (10 listed)
- Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection.
- Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing).
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion.
- Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids.
- (Stable treated CNS disease may be allowed per protocol.)
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 |
|---|---|---|
| EB-PT-CAR-NK-Ssingle-target CAR-NK cell infusion, IV | Biological | Arm A: Single-target precision-matched CAR-NK, Arm B: Dual-target precision-matched CAR-NK |
| EB-PT-CAR-NK-Ddual-target CAR-NK cell infusion, IV | Biological | Arm A: Single-target precision-matched CAR-NK, Arm B: Dual-target precision-matched CAR-NK |
| Lymphodepleting chemotherapyfludarabine + cyclophosphamide | Drug | Arm A: Single-target precision-matched CAR-NK, Arm B: Dual-target precision-matched CAR-NK |
| Cytokine supportlow-dose IL-2 or IL-15 agonist | Drug | Arm A: Single-target precision-matched CAR-NK, Arm B: Dual-target precision-matched CAR-NK |
Primary outcome
Dose- limiting toxicities
Time frame: 28 days
Dose limiting toxicities refer to specific adverse events or side effects that prevent further dose escalation of an investigational drug or therapy in a clinical trial. DLTs are pre-defined based on severity, duration, and impact on patient safety, typically graded according to established criteria such as the Common Terminology Criteria for Adverse Events (CTCAE). Monitoring DLTs is a critical outcome measure in early-phase (Phase I/II) studies, as it helps determine the maximum tolerated dose (MTD) and guides safe dosing for subsequent trial phases.
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 6 Apr 2026.
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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 EB-PT-CAR-NK-S, EB-PT-CAR-NK-D and Lymphodepleting chemotherapy in people with Advanced or Metastatic Solid Tumors, 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 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 shan 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?
Dose- limiting toxicities (time frame: 28 days). 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 6 Apr 2026.