Brain MetastasisEarly Phase 1NCT07656103
QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors
A Early Phase 1 study testing QH101 Cell Injection in people with Brain Metastasis and Meningeal Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis, Meningeal Metastasis, Spinal Cord Metastasis
- What is being tested?
- QH101 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2026to 31 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- ECOG ≤2 or KPS ≥60;
- Life expectancy ≥8 weeks as assessed by the investigator;
- Pathologically and/or histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;
- Intracranial metastases must meet the following characteristics:
- Unresectable by craniotomy for solitary/focal (≤3 lesions)/multiple (>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy/stereotactic radiosurgery (WBRT/SRS), and are not suitable for repeat radiotherapy;
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- For brain/spinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);
- Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):
- White blood cell count (WBC) ≥ 3 × 10⁹/L; Lymphocyte count (LY) ≥ 0.8 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L; Platelet count (PLT) ≥ 90 × 10⁹/L; Alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) < 1.5×ULN; Serum creatinine (Cr) < 1.5×ULN; Total bilirubin < 1.5×ULN; PT \& APTT ≤ 1.25×ULN.
- Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;
- Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;
- Signing of the trial informed consent form.
Who cannot join
- Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;
- Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;
- Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1/2 segments of the cervical spinal cord;
- Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);
- Patients with primary or secondary epilepsy/epileptic syndrome that is difficult to control with medication;
- Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting patient compliance with study requirements;
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- Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;
- Currently receiving any other investigational treatments;
- Diagnosed with an immunodeficiency;
- Patients with active infections requiring systemic treatment;
- Inability to undergo magnetic resonance imaging (MRI);
- Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;
- Allergic to immunotherapy or related cellular therapies;
- Previously received CAR-T or other cellular immunotherapies;
- Other reasons that the investigator considers make the patient unsuitable for participation in this study.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
LiNing M.D., +86010-87788165, lining@cicams.ac.cn
About this study
Official title: Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig
QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.
Read the detailed description
This is an early-phase clinical study conducted to initially evaluate the safety, tolerability, and preliminary biological activity of QH101, an allogeneic TCR-enhanced Vδ2 T cell therapy, in patients with advanced solid tumors who have exhausted standard treatment options. The study adopts an open-label, non-randomized design to fully observe the in vivo performance of QH101, which is engineered to express BTN protein-specific binding elements without co-stimulatory signal domains or the CD3ζ domain.
Prior to QH101 infusion, eligible patients will receive a standardized lymphodepletion regimen to create a favorable immune microenvironment for the homing, expansion, and persistence of infused Vδ2 T cells. QH101 will be administered via intravenous infusion, with a gradual dose-escalation strategy implemented to explore the safe dose range. Throughout the study, patients will undergo close clinical monitoring to track any adverse events associated with the therapy, with a particular focus on immune-related toxicities and infusion-related reactions, given the unique design of QH101 that avoids T cell exhaustion from overactivation.
In addition to safety monitoring, the study will collect serial peripheral blood samples at predefined time points to assess the in vivo persistence, activation status, and tissue homing potential of QH101. Correlative studies will be conducted to explore the interaction between QH101 and the tumor microenvironment, especially the binding efficiency of BTN protein-specific binding elements to tumor-expressed BTN2A1/BTN3A1, as well as the relationship between the in vivo dynamics of QH101 and preliminary antitumor activity.
The primary goal of this early clinical research is to confirm the safety profile of QH101, determine the feasible dose range for subsequent studies, and obtain preliminary evidence of its biological activity, including in vivo persistence and tumor-targeting capability. The findings from this study will lay a solid foundation for the further clinical development of QH101, providing critical insights into its potential as a novel cellular therapy for advanced solid tumors.
- Being tested
- QH101 Cell Injection
- Keywords
- TCR, BTN, γδT, allogeneic cell therapy
- Medical subject headings
- Brain Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QH101 Cell InjectionDrug
dose escalation (3+3) : dose 1 (1×107enTCR Vδ2T cells) , dose 2 (3×107enTCR Vδ2T cells), dose 3 (6×107enTCR Vδ2T cells)
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cord | Experimental | Patients with malignant solid tumors metastasizing to the brain, meninges, or spinal cord receive QH101 cell injection solution via intrathecal injection or Ommaia reservoir infusion. Receives: Drug: QH101 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Adverse events (AEs) are defined as any adverse medical events occurring from the onset of lumbar puncture catheter implantation in subjects (for subjects who had an Ommaya reservoir implanted before enrollment, events are recorded from the start of cell infusion) up to 12 months after the completion of QH101 infusion. Among these, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) standards; graft-versus-host disease (GVHD) is graded according to the Mount Sinai Acute GVHD International Consortium definitions. Other AEs are graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Measured: From the date of the subject's signing of the informed consent to one year following completion of treatment.
Neurological function assessment
Neurological function assessment is performed using the NANO scale. The NANO scale (see Appendix 2 for the NANO scale) assesses subjects' neurological symptoms across 9 domains: gait, muscle strength, upper limb ataxia, sensory function, visual field, facial strength, speech, consciousness status, and daily performance.Relative to the baseline or previous assessment, a total score change of -1 to +1 is defined as stable symptoms, a change of -2 to -3 as worsened symptoms, and a change of +2 to +3 as improved symptoms.
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Cerebrospinal fluid cytology assessment
Cerebrospinal fluid tumor cell assessment and cerebrospinal fluid biochemical testing for cerebrospinal fluid cytology evaluation CSF cytological results are evaluated using a binary classification system. Negative results are defined as true negative or atypical, while positive results are defined as true positive or suspicious positive.
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Neuroimaging Assessment
Neuroimaging assessment through imaging studies
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Secondary outcomes (3)
Quality of life assessment
Use the M.D. Anderson Symptom Assessment Scale for Brain Tumors (MDASI-BT) to assess the quality of life for all enrolled subjects.
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Pharmacokinetics（PK）
Changes in the number of γδ T cells, their subsets/differentiation/exhaustion, and cytokines in cerebrospinal fluid
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Pharmacodynamics (PD)
Changes in the number of γδ T cells, cell subsets/differentiation/exhaustion, and cytokines in cerebrospinal fluid
Measured: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhang Wang, Study director, NCC, CICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656103
- Sponsor's protocol ID
- QH1010401-SBM-01（0）
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig
- ClinicalTrials.gov ID
- NCT07656103
- Acronym / sponsor ID
- QH1010401-SBM-01（0）
- Keywords
- TCR, BTN, γδT, allogeneic cell therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Jun 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.
QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.
Detailed description
This is an early-phase clinical study conducted to initially evaluate the safety, tolerability, and preliminary biological activity of QH101, an allogeneic TCR-enhanced Vδ2 T cell therapy, in patients with advanced solid tumors who have exhausted standard treatment options. The study adopts an open-label, non-randomized design to fully observe the in vivo performance of QH101, which is engineered to express BTN protein-specific binding elements without co-stimulatory signal domains or the CD3ζ domain.
Prior to QH101 infusion, eligible patients will receive a standardized lymphodepletion regimen to create a favorable immune microenvironment for the homing, expansion, and persistence of infused Vδ2 T cells. QH101 will be administered via intravenous infusion, with a gradual dose-escalation strategy implemented to explore the safe dose range. Throughout the study, patients will undergo close clinical monitoring to track any adverse events associated with the therapy, with a particular focus on immune-related toxicities and infusion-related reactions, given the unique design of QH101 that avoids T cell exhaustion from overactivation.
In addition to safety monitoring, the study will collect serial peripheral blood samples at predefined time points to assess the in vivo persistence, activation status, and tissue homing potential of QH101. Correlative studies will be conducted to explore the interaction between QH101 and the tumor microenvironment, especially the binding efficiency of BTN protein-specific binding elements to tumor-expressed BTN2A1/BTN3A1, as well as the relationship between the in vivo dynamics of QH101 and preliminary antitumor activity.
The primary goal of this early clinical research is to confirm the safety profile of QH101, determine the feasible dose range for subsequent studies, and obtain preliminary evidence of its biological activity, including in vivo persistence and tumor-targeting capability. The findings from this study will lay a solid foundation for the further clinical development of QH101, providing critical insights into its potential as a novel cellular therapy for advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cord | Experimental | Drug: QH101 Cell InjectionPatients with malignant solid tumors metastasizing to the brain, meninges, or spinal cord receive QH101 cell injection solution via intrathecal injection or Ommaia reservoir infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years;
- ECOG ≤2 or KPS ≥60;
- Life expectancy ≥8 weeks as assessed by the investigator;
- Pathologically and/or histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;
- Intracranial metastases must meet the following characteristics:
Key exclusion criteria (15 listed)
- Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;
- Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;
- Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1/2 segments of the cervical spinal cord;
- Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);
- Patients with primary or secondary epilepsy/epileptic syndrome that is difficult to control with medication;
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 |
|---|---|---|
| QH101 Cell Injectiondose escalation (3+3) : dose 1 (1×107enTCR Vδ2T cells) , dose 2 (3×107enTCR Vδ2T cells), dose 3 (6×107enTCR Vδ2T cells) | Drug | Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cord |
Primary outcome
AEs
Time frame: From the date of the subject's signing of the informed consent to one year following completion of treatment.
Adverse events (AEs) are defined as any adverse medical events occurring from the onset of lumbar puncture catheter implantation in subjects (for subjects who had an Ommaya reservoir implanted before enrollment, events are recorded from the start of cell infusion) up to 12 months after the completion of QH101 infusion. Among these, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) standards; graft-versus-host disease (GVHD) is graded according to the Mount Sinai Acute GVHD International Consortium definitions. Other AEs are graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Neurological function assessment
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Neurological function assessment is performed using the NANO scale. The NANO scale (see Appendix 2 for the NANO scale) assesses subjects' neurological symptoms across 9 domains: gait, muscle strength, upper limb ataxia, sensory function, visual field, facial strength, speech, consciousness status, and daily performance.Relative to the baseline or previous assessment, a total score change of -1 to +1 is defined as stable symptoms, a change of -2 to -3 as worsened symptoms, and a change of +2 to +3 as improved symptoms.
Cerebrospinal fluid cytology assessment
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Cerebrospinal fluid tumor cell assessment and cerebrospinal fluid biochemical testing for cerebrospinal fluid cytology evaluation CSF cytological results are evaluated using a binary classification system. Negative results are defined as true negative or atypical, while positive results are defined as true positive or suspicious positive.
Neuroimaging Assessment
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Neuroimaging assessment through imaging studies
3 secondary outcomes
Quality of life assessment
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Pharmacokinetics（PK）
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Pharmacodynamics (PD)
Time frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
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 18 Jun 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.
Shuhang Wang study director
NCC, CICAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing QH101 Cell Injection in people with Brain Metastasis and Meningeal Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 15 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 18 Jun 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 Li Ning M.D (+8601087788165, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: From the date of the subject's signing of the informed consent to one year following completion of treatment.). The study lists 4 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 18 Jun 2026.