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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: through study completion, an average of 1 year
Dose Limiting Toxicity (DLT)
Time frame: 28 days
Immune effector cell-associated neurotoxicity syndrome (ICANs)
Time frame: through study completion, an average of 1 year
GvHD
Time frame: through study completion, an average of 1 year
CRS
Time frame: through study completion, an average of 1 year
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