CSPC：SYS6055 has received its first clinical trial approval.
In January 2026, CSPC Pharmaceutical Group’s SYS6055 Injection received clinical trial approval for the treatment of relapsed/refractory aggressive B-cell lymphoma. According to the Insight database, this is the first in vivo CAR-T product approved by the CDE to enter registrational clinical trials.
For the development of in vivo CAR-T therapy, the core enabling technology lies in the delivery system — how to precisely, efficiently, and safely deliver the CAR gene to target T cells within the patient’s body. Currently, commonly used CAR delivery systems in clinical research include viral vectors and non-viral vectors.
SYS6055 is an in vivo CAR-T product targeting CD19, utilizing a lentiviral vector. CSPC Pharmaceutical Group is currently conducting a Phase I/II clinical study (CTR20260705) to evaluate the safety and tolerability of SYS6055 in patients with relapsed/refractory aggressive CD19-positive B-cell lymphoma. The trial plans to enroll 374 patients, with primary completion date expected in March 2029.
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