QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors

June 14, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years;
  2. ECOG ≤2 or KPS ≥60;
  3. Life expectancy ≥8 weeks as assessed by the investigator;
  4. 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;

  5. 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;

  6. 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);

  7. 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.

  8. 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;
  9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;
  10. Signing of the trial informed consent form.

Exclusion Criteria:

  1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;
  2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;
  3. 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;
  4. 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);
  5. Patients with primary or secondary epilepsy/epileptic syndrome that is difficult to control with medication;
  6. 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;
  7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;
  8. Currently receiving any other investigational treatments;
  9. Diagnosed with an immunodeficiency;
  10. Patients with active infections requiring systemic treatment;
  11. Inability to undergo magnetic resonance imaging (MRI);
  12. 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;
  13. Allergic to immunotherapy or related cellular therapies;
  14. Previously received CAR-T or other cellular immunotherapies;
  15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cord
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.
Drug: QH101 Cell Injection
dose escalation (3+3) : dose 1 (1×107enTCR Vδ2T cells) , dose 2 (3×107enTCR Vδ2T cells), dose 3 (6×107enTCR Vδ2T cells)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From the date of the subject's signing of the informed consent to one year following completion of treatment.
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.
Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
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.
Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Neuroimaging Assessment
Time Frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Neuroimaging assessment through imaging studies
Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life assessment
Time Frame: Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.
Use the M.D. Anderson Symptom Assessment Scale for Brain Tumors (MDASI-BT) to assess the quality of life for all enrolled subjects.
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.
Changes in the number of γδ T cells, their subsets/differentiation/exhaustion, and cytokines in cerebrospinal fluid
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.
Changes in the number of γδ T cells, cell subsets/differentiation/exhaustion, and cytokines in cerebrospinal fluid
Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shuhang Wang, NCC, CICAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QH1010401-SBM-01（0）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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