About this trial
The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of ±7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in this study and sign the informed consent form.
Be aged between 18 and 70 years old (including the critical values), with no gender limitation.
Subjects with high-grade glioma diagnosed pathologically (referring to grade 3 or 4 in the "WHO (2021) Classification of Tumors of the Central Nervous System"), who have progressive disease during standard treatment or have recurrence after standard treatment.
Enhanced MRI shows space-occupying lesions in the brain, and there is at least one measurable lesion (according to the iRANO 2010 version criteria).
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
MT027 cells suspension
DrugMT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells
Treatment groups
Trial outcomes
Primary outcomes
Adverse Events (AE) and Serious Adverse Events (SAE)
Dose Limiting Toxicity (DLT)
Immune effector cell-associated neurotoxicity syndrome (ICANs)
GvHD
Sponsors and contacts
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