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

ConditionsBrain Metastasis Meningeal Metastasis Spinal Cord Metastasis

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Sequential

Treatments tested in this trial

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)

Treatment groups

7 Participants

are divided into 1 treatment group

Group A: Patients with metastatic malignant solid tumors to the brain, meninges, and spinal cordExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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.

Time frame