Solid TumorPhase 1/2CAR001NCT06150885
A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors
A Phase 1/2 study testing HLA-G-CAR.BiTE allogeneic γδ T cells in people with Solid Tumor, run by Ever Supreme Bio Technology Co., Ltd. at 2 sites in Taiwan.
Trial summary
This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HLA-G-CAR.BiTE allogeneic γδ T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Sep 2024to 30 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years
- For phase I part, subjects with histologically confirmed diagnosis of unresectable local advanced or metastatic solid tumor with expression of both PD-L1 and HLA-G positive are relapsed/refractory to at least two lines of standard-of-care therapy, or unwilling to undergo standard therapies.
- Relapse is defined as disease progression after last regimen; refractory is defined as intolerable or progressing disease (PD), or stable disease (SD) to the last regimen.
- For phase IIa part, subjects with histologically confirmed diagnosis of unresectable local advanced or metastatic BC, NSCLC, CRC or GBM with expression of both PD-L1 and HLA-G positive, and are relapsed/refractory to at least two lines of standard-of-care therapy, or unwilling to undergo standard therapies.
- Relapse is defined as disease progression after last regimen; refractory is defined as intolerable or progressing disease (PD) to the last regimen or stable disease (SD) without meaningful clinical benefit as determined by the investigator.
- The standard-of-care therapies of phase IIa for each disease are listed:
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- BC: Subject failed to anthracycline-containing (such as Doxorubicin and Epirubicin), taxane-containing (such as Paclitaxel and Docetaxel), antimetabolites (such as Capecitabine, Gemcitabine and Fluorouracil) or platinum-based (such as Cisplatin and Carboplatin) chemotherapy, microtubule dynamic inhibitor (such as Eribulin and Vinorelbine) and/or targeted therapy such as antibody drug conjugate (such as Sacituzumab govitecan-hzi), PARP inhibitor, germline BRCA1/BRCA2 mutation (such as Olaparib and Talazoparib), HER2-targeted therapy for HER2-positive disease and endocrine therapy for hormone receptor-positive disease..
- NSCLC: Subject failed to targeted therapies (according to the genetic testing results), such as Gefitinib and Afatinib and/or platinum-containing, pemetrexed, docetaxel chemotherapy with or without Immune checkpoint inhibitors (such as PD-1 or PD-L1 inhibitor: Atezolizumab, Nivolumab, and Pembrolizumab). For subject with non-squamous cell carcinoma using Immune checkpoint inhibitor, subjects should be with EGFR/ALK/ROS-1 wild type; for subject with squamous cell carcinoma using Immune checkpoint inhibitor, subjects should be with EGFR/ALK wild type.
- CRC: Subject failed to chemotherapies (i.e. Folinicacid/ 5-fluorouracil/oxaliplatin (FOLFOX) and Folinicacid/ 5-fluorouracil/irinotecan (FOLFIRI)) and/or target therapies, including anti-EGFR (K-RAS and N-RAS wild type) (such as Cetuximab and Panitumumab) or anti-VEGF (such as Bevacizumab), Regorafenib and Lonsurf, according to the genetic testing results) GBM: Subject failed to chemotherapy (such as Temozolomide (TMZ)) Carmustine implant (such as Gliadel Wafer) and/or anti-VEGF (such as Bevacizumab) treatment
- With at least one measurable lesion as defined by RECIST1.1 (for BC, NSCLC or CRC) or RANO (for GBM). For subjects with GBM, the maximum longest diameter (or perpendicular diameter for CNS lesions) not exceeding 3.0 cm (≤ 3.0 cm) at screening.
- Able to understand and sign the informed consent form (ICF)
- Have a life expectancy of > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Recovered from any previous therapy related toxicity to ≤ grade 2 at screening
- With adequate renal function: serum creatinine ≤ 1.5X upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) > 50 ml/min
- With adequate liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3X ULN or ≤ 5 X ULN if liver metastases; and total bilirubin ≤ 1.5 X ULN or ≤ 3 X ULN if due to Gilbert's disease.
- With prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5X ULN
- With adequate hematopoietic function:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/μl
- Platelets ≥ 75,000 counts/μl
- Total white blood cell (WBC) ≥ 2,000 cells/μl
- Hemoglobin ≥ 8 g/dL
Who cannot join
- Has received autologous cell therapy or autologous tissue transplantation within 180 days before CAR001 infusion; or with a history of allogeneic or xenogeneic transplant, gene therapy or BiTE therapy
- With known or suspected to be hypersensitivity to CAR001 or its excipients, such as DMSO or human serum albumin
- With more than one kind of active diagnosed primary cancer
- With active infection requiring systemic medication
- With medical conditions who are receiving systemic steroid therapy >10 mg prednisone/day or equivalent dose, or other immune-suppressants in the past 2 weeks
- With active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) at the time of Screening. Suspected SARS-CoV-2 confirmed positive by PCR, or suspected tuberculosis infection.
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- Active HBV infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test during Screening. Subjects with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBc Ab) test at screening are eligible for the study if HBV deoxyribonucleic acid (DNA) test is ≤ 1000 copies/mL.
- Active HCV infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test during Screening. The HCV RNA test will be performed only for subjects who have a positive HCV test. Subjects with a history of treated HCV can be enrolled if negative by HCV PCR with investigator approval.
- With acute cardiovascular disease; New York Heart Association (NYHA) classification ≥ 3; or history of myocardial infarction during the past 6 months; or has active uncontrolled arterial hypertension by medical history; Or cardiac LVEF ≤ 40%, evidence of pericardial effusion as determined by echocardiogram (ECHO), and clinically significant pleural effusion; or uncontrolled cardiac arrhythmia; or cardiac enzyme levels including N-terminal -pro B type natriuretic peptide (NT-proBNP) > 450 pg/ml (age <50 yrs); > 900 pg/ml (age 50-75 yrs); > 1,800 pg/ml (age >75 yrs) by blood sampling. Per investigator's judgment, would not make participation appropriate
- With historical or current auto-immune diseases, such as rheumatoid arthritis, type I diabetes, psoriasis or systemic lupus erythematosus
- Has uncontrolled psychiatric disorder by medical history
- Has central nerve system (CNS) diseases except GBM or stroke (acute stroke within 6 months is excluded)
- With treated CNS metastases (by whole brain radiation therapy, surgery or radiosurgery, etc.) are permitted on study if all of the following are met:
- CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastases
- With medical conditions who are on a stable dose of ≤10mg/day of prednisone or equivalent for at least 2 weeks
- Has received any investigational therapy from another clinical study within the last 4 weeks prior to CAR001 infusion
- Inability to undergo radiological assessment, such as MRI or CT for any reason
- Has received radiotherapy or chemotherapy within 2 weeks prior to CAR001 infusion; or targeted therapy or monoclonal antibodies within 4 weeks before CAR001 infusion
- With historical record indicating a high disease burden, such as >5% bone marrow lymphoblasts or any peripheral blood lymphoblasts. Per investigator's judgement would not be eligible for participation.
- Has experienced severe CRS during previous treatments
- Not suitable to participate the trial as judged by the investigator
- With spinal cord compression, primary or metastatic brain tumors causing new neurological symptoms or unstable neurological symptoms, or those experiencing mass effect due to tumors requiring intervention therapy
- Has received any therapy that target HLA-G
- Female subject of childbearing potential who:
- Is lactating; or
- Has a positive pregnancy test result at eligibility checking; or
- Refuses to adopt at least two forms of birth control from signing informed consent to 1 year after the last administration of CAR001.
- Male subject with a female spouse/partner who is of childbearing potential refuses to adopt at least two forms of birth control from signing informed consent to 1 year after the last administration of CAR001.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, Non-US, 404
Der-Yang Cho, MD, d5057@mail.cmuh.org.tw
Tao-Wei Ke, MD
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jen-Yu Chong, MD, +88623123456
Po-Hao Huang, MD
About this study
Official title: A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects With Relapsed/Refractory Solid Tumors
This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).
Read the detailed description
Primary Objective:
Phase I:
To evaluate the safety of CAR001 in subjects.
Phase IIa:
To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects.
Secondary Objectives:
To evaluate the safety and potential efficacy of CAR001 in subjects.
Exploratory:
Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits. (Time Frame: 12 months after the last infusion)
- Conditions
- Solid Tumor
- Being tested
- HLA-G-CAR.BiTE allogeneic γδ T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-G-CAR.BiTE allogeneic γδ T cellsBiological
Phase I is a multiple escalating dose, single arm, open-label and 3+3 design that implemented with five cohorts: low dose for single administration, low dose for twice administrations for 2 weeks, low, middle and high dose for 4 repeated administrations for 4 weeks.
Phase IIa is a single-arm, open-label and dose-expansion study and the effective dose of CAR-positive cells will be administered to 27 evaluable subjects with TNBC, NSCLC, CRC or GBM via intravenous infusion weekly for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CAR001 | Experimental | CAR001 cells mixed with normal saline will be administered to patients. Receives: Biological: HLA-G-CAR.BiTE allogeneic γδ T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of CAR001 for Phase I part
MTD was determined by testing increasing doses once a week for 4 weeks via IV on dose escalation cohorts 1 to 5 with 3 to 6 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any AE ≥ grade 3 (CTCAE v5.0) that is considered to be causally related (possibly, probably, or definitely related) to CAR001 within 4 weeks.
Measured: 4 weeks after last dosing of CAR001
Objective Response Rate (ORR) of CAR001 for Phase IIa part
The rate of subjects with CR or PR based on RECIST1.1 in patients with NSCLC, TNBC or CRC; RANO in patients with GBM. Although there is no control group in this study, the ORR after CAR001 administration could be compared to baseline.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Secondary outcomes (9)
Safety - AEs and SAEs incidences over the study period
The incidence of AEs and SAE from screening to the end of study or until documented disease progression.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Vital signs assessments at each post-treatment
Changes of vital signs at each post-treatment measurement or until documented disease progression from baseline.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Laboratory examinations at each post-treatment
Changes of laboratory data at each post-treatment measurement or until documented disease progression from baseline.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - 12-lead electrocardiogram (ECG) assessments at each post-treatment
Changes of ventricular rate, PR interval, QRS interval, and QT interval by 12-lead ECG at each post-treatment measurement or until documented disease progression from baseline.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Physical Examination at each post-treatment
Abnormality in physical examination at each post-treatment measurement or until documented disease progression from baseline.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Progression Free Survival (PFS) rate
Time from 1st CAR001 administration to disease progression determined by MRI or CT, or death of the subject whichever comes first. Subjects who do not occur disease progression or mortality until the EOS will be considered as right-censored. Although there is no control group in this study, the PFS after CAR001 administration could be compared to historical data.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Overall Survival (OS) rate
Time from 1st CAR001 administration to death. Subjects who do not die until the end of study will be considered as right-censored. Although there is no control group in this study, the OS after CAR001 administration could be compared to historical data. After the EOS, the OS should be followed every 3 months by phone contact.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Change of QoL from baseline
QoL will be assessed by EORTC QLQ-C30 version 3.0 from baseline to subsequent evaluation visits or until documented disease progression.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Change of ECOG Performance Status Scale
ECOG Performance Status Scale will be assessed from baseline to subsequent evaluation visits or until documented disease progression.
Measured: from visit 1 to 24-months of safety and efficacy follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen-Liang Huang, MD, Study chair, Ever Supreme Bio Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150885
- Sponsor's protocol ID
- ES-CCAR01-A3301
- Acronym
- CAR001
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Huang SW, Pan CM, Lin YC, Chen MC, Chen Y, Jan CI, Wu CC, Lin FY, Wang ST, Lin CY, Lin PY, Huang WH, Chiang YT, Tsai WC, Chiu YH, Lin TH, Chiu SC, Cho DY. BiTE-Secreting CAR-gammadeltaT as a Dual Targeting Strategy for the Treatment of Solid Tumors. Adv Sci (Weinh). 2023 Jun;10(17):e2206856. doi: 10.1002/advs.202206856. Epub 2023 Apr 20.
PubMed 37078788
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects With Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT06150885
- Acronym / sponsor ID
- CAR001 / ES-CCAR01-A3301
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Nov 2023 (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 study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).
Detailed description
Primary Objective:
Phase I:
To evaluate the safety of CAR001 in subjects.
Phase IIa:
To provide potential evidence for the clinical efficacy of CAR001 in improving tumor response rate in subjects.
Secondary Objectives:
To evaluate the safety and potential efficacy of CAR001 in subjects.
Exploratory:
Level of CAR-positive γδT cells in peripheral blood from baseline to subsequent visits. (Time Frame: 12 months after the last infusion)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| CAR001 | Experimental | Biological: HLA-G-CAR.BiTE allogeneic γδ T cellsCAR001 cells mixed with normal saline will be administered to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female subjects aged ≥ 18 years
- For phase I part, subjects with histologically confirmed diagnosis of unresectable local advanced or metastatic solid tumor with expression of both PD-L1 and HLA-G positive are relapsed/refractory to at least two lines of standard-of-care therapy, or unwilling to undergo standard therapies.
- Relapse is defined as disease progression after last regimen; refractory is defined as intolerable or progressing disease (PD), or stable disease (SD) to the last regimen.
- For phase IIa part, subjects with histologically confirmed diagnosis of unresectable local advanced or metastatic BC, NSCLC, CRC or GBM with expression of both PD-L1 and HLA-G positive, and are relapsed/refractory to at least two lines of standard-of-care therapy, or unwilling to undergo standard therapies.
- Relapse is defined as disease progression after last regimen; refractory is defined as intolerable or progressing disease (PD) to the last regimen or stable disease (SD) without meaningful clinical benefit as determined by the investigator.
Key exclusion criteria (28 listed)
- Has received autologous cell therapy or autologous tissue transplantation within 180 days before CAR001 infusion; or with a history of allogeneic or xenogeneic transplant, gene therapy or BiTE therapy
- With known or suspected to be hypersensitivity to CAR001 or its excipients, such as DMSO or human serum albumin
- With more than one kind of active diagnosed primary cancer
- With active infection requiring systemic medication
- With medical conditions who are receiving systemic steroid therapy >10 mg prednisone/day or equivalent dose, or other immune-suppressants in the past 2 weeks
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 |
|---|---|---|
| HLA-G-CAR.BiTE allogeneic γδ T cellsPhase I is a multiple escalating dose, single arm, open-label and 3+3 design that implemented with five cohorts: low dose for single administration, low dose for twice administrations for 2 weeks, low, middle and high dose for 4 repeated administrations for 4 weeks. Phase IIa is a single-arm, open-label and dose-expansion study and the effective dose of CAR-positive cells will be administered to 27 evaluable subjects with TNBC, NSCLC, CRC or GBM via intravenous infusion weekly for 4 weeks. | Biological | CAR001 |
Primary outcome
Maximum Tolerated Dose (MTD) of CAR001 for Phase I part
Time frame: 4 weeks after last dosing of CAR001
MTD was determined by testing increasing doses once a week for 4 weeks via IV on dose escalation cohorts 1 to 5 with 3 to 6 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any AE ≥ grade 3 (CTCAE v5.0) that is considered to be causally related (possibly, probably, or definitely related) to CAR001 within 4 weeks.
Objective Response Rate (ORR) of CAR001 for Phase IIa part
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
The rate of subjects with CR or PR based on RECIST1.1 in patients with NSCLC, TNBC or CRC; RANO in patients with GBM. Although there is no control group in this study, the ORR after CAR001 administration could be compared to baseline.
9 secondary outcomes
Safety - AEs and SAEs incidences over the study period
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Vital signs assessments at each post-treatment
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Laboratory examinations at each post-treatment
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - 12-lead electrocardiogram (ECG) assessments at each post-treatment
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Safety - Physical Examination at each post-treatment
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Progression Free Survival (PFS) rate
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Overall Survival (OS) rate
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Change of QoL from baseline
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
Efficacy - Change of ECOG Performance Status Scale
Time frame: from visit 1 to 24-months of safety and efficacy follow-up period
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 9 Sep 2026.
- Background: PubMed 37078788Huang SW, Pan CM, Lin YC, Chen MC, Chen Y, Jan CI, Wu CC, Lin FY, Wang ST, Lin CY, Lin PY, Huang WH, Chiang YT, Tsai WC, Chiu YH, Lin TH, Chiu SC, Cho DY. BiTE-Secreting CAR-gammadeltaT as a Dual Targeting Strategy for the Treatment of Solid Tumors. Adv Sci (Weinh). 2023 Jun;10(17):e2206856. doi: 10.1002/advs.202206856. Epub 2023 Apr 20.
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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.
Wen-Liang Huang, MD study chair
Ever Supreme Bio Technology Co., Ltd.
2 sites 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 HLA-G-CAR.BiTE allogeneic γδ T cells in people with Solid Tumor, run by Ever Supreme Bio Technology Co., Ltd. at 2 sites in Taiwan.
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 22 inclusion and 28 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 Sammi Hsu (+886422052121, cthsu@ever-supreme.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of CAR001 for Phase I part (time frame: 4 weeks after last dosing of CAR001). 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 NCT06150885, which also lists 1 linked publication.
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 9 Sep 2026.