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

NCT07656103 | Not Yet Recruiting Early Phase 1

• 1 other identifier: QH1010401-SBM-01（0）
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Brain Metastasis; Meningeal Metastasis; Spinal Cord Metastasis

Keywords

TCR; BTN; γδT; allogeneic cell therapy

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

• Neuroimaging Assessment

  Neuroimaging assessment through imaging studies

  Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

Secondary Outcomes (3)

• Quality of life assessment

  Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

• Pharmacokinetics（PK）

  Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

• Pharmacodynamics (PD)

  Prior to cell infusion, and at months 1, 3, 6, 9 and 12 post-infusion.

Study Arms (1)

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.

Drug: QH101 Cell Injection

Interventions

QH101 Cell Injection DRUG

dose escalation (3+3) : dose 1 (1×107enTCR Vδ2T cells) , dose 2 (3×107enTCR Vδ2T cells), dose 3 (6×107enTCR Vδ2T cells)

Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cord

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Meningeal Neoplasms

Study Officials

• Shuhang Wang

  NCC, CICAMS

  STUDY DIRECTOR

Central Study Contacts

Li Ning M.D

CONTACT

+8601087788165; lining@cicams.ac.cn

Shuhang Wang

CONTACT

13552715820; snowflake201@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: June 18, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)