"Get lost, this is annoying!" That was the response a reporter received on September 2 when calling Li Mouxin, a director of Immuncell Biotechnology Co., Ltd. (hereinafter "Immuncell"), regarding the death of a clinical trial participant. The incident involves 49-year-old gastric cancer patient Zhan (pseudonym), who enrolled in a CAR-T cell clinical trial conducted by Immuncell at Shanghai Changhai Hospital. Hours after receiving the investigational drug infusion on the same day, the patient suddenly developed bilateral subdural hematoma and brain herniation, requiring emergency craniotomy. He remained in a coma post-surgery and ultimately died in the ICU.
In an exclusive interview, the patient's wife, Ms. Cheng, stated that the informed consent form failed to adequately disclose all risks, and that post-treatment care at the hospital was substandard. "They owe me an explanation. This is a serious adverse event that must be reported by regulation. Can't they give the family an answer?" When contacted, the ethics committee at Changhai Hospital said they were not familiar with the matter and declined to comment. Calls to Immuncell's official phone line went unanswered.
Notably, just 15 days before the incident came to light, Immuncell had resubmitted its listing application to the Hong Kong Stock Exchange main board, seeking to go public as a pre-commercialization biotech company. This marks the company's second attempt at a Hong Kong IPO. The proceeds are primarily earmarked for clinical development and commercialization preparation of its lead product IMC002, alongside advancing its in vivo CAR-T platform and multiple pipeline programs.
Industry insiders suggest that the IPO review timeline will likely be significantly extended. Under Hong Kong Stock Exchange rules, pre-revenue biotech companies must disclose all material safety data — including any significant adverse events — related to their core products in listing documents, along with potential clinical trial risks. This death likely qualifies as a serious adverse event (SAE). If this incident is not fully and timely reflected in the prospectus, the exchange will issue inquiries, and sponsors will need to conduct supplementary investigations into the events, causal assessment, and ethics committee findings. Multiple rounds of inquiries are almost certain.
The informed consent form did not mention potential intracranial bleeding
The informed consent form is the most critical document in drug trials. A key point of contention is whether the risk of bilateral subdural hematoma and brain herniation, occurring hours after infusion, was adequately disclosed in advance. As the patient's spouse, Ms. Cheng was involved throughout her husband's cancer treatment and clinical trial participation. She recalls that before signing the consent form, the attending physician had communicated with them multiple times.
"We had known each other for quite a while. He was our attending physician and the surgeon who performed the gastrectomy in March 2025. After surgery, the patient completed six cycles of first-line chemotherapy, but the condition showed some recurrence, so the doctor recommended enrolling in the trial." According to Ms. Cheng, her 49-year-old husband was the family's breadwinner. As recently as January 2026, he was still handling work online and meeting colleagues. "He hoped for better outcomes and still had expectations for a normal life."
"If you can't trust the doctor, who can you trust? He certainly knows more than we do, right?" Ms. Cheng recalled that during preliminary discussions, the doctor mentioned various trial-related matters, noting that the main risk was cytokine release syndrome. The doctor assured them that there were well-established clinical protocols to manage this side effect and that the risk was controllable. Her husband subsequently signed the consent form. Among the risks listed in the form was a brief mention of potential "CAR-T-related coagulation disorders." Ms. Cheng acknowledged, "We did review all the risks on the form," but emphasized that it never disclosed the possibility of "intracranial hemorrhage" or "brain herniation." "If such a risk had been listed, who would have agreed?" In subsequent communications, the pharmaceutical company cited this same clause in response to the family's concerns.
"Was my husband just sleeping?"
"The night was hellish," Ms. Cheng said, unable to let go of several scenes from the day of the infusion. She believes the hospital failed to provide adequate care after the procedure. The consent form was signed on January 14, followed by preparatory work. On March 2, the prepared cells were infused. "The infusion was supposed to be completed around noon, but by 7:30 in the evening, he couldn't be roused," Ms. Cheng said. She noticed something was wrong and called for medical staff, who responded that the patient was sleeping. At that point, Zhan displayed lethargy and was unresponsive. Multiple doctors and nurses came to check on him and attached a cardiac monitor, which showed normal readings throughout.
"We asked if this was normal, and two or three groups of doctors all said he was catching up on sleep — that the lymphodepletion chemotherapy had left him weak and he was resting." Ms. Cheng said the family grew increasingly concerned and sought help again. Around 7:30 PM, doctors examined him, checked his pupils, and tested for responses to stimulation. Only then did they realize the patient couldn't be awakened. An immediate CT scan revealed bilateral subdural hematoma and brain herniation — a life-threatening condition. Around 10 PM, he underwent emergency craniotomy.
Ms. Cheng still remembers their last conversation. In the mid-afternoon of that day, Zhan was conscious and able to eat. "I told him his supervisor had asked about his condition. He asked me to pass along that he was okay." That was the last sentence they exchanged. "After that, he fell asleep. I really thought he was sleeping, because even the doctors said so." The craniotomy lasted from around 10 PM until 5 AM the next day. Regrettably, the patient never regained consciousness. Before the surgery, doctors had already informed Ms. Cheng that even if the operation succeeded, the patient would most likely remain in a vegetative state.
Immuncell had just filed its listing application
Zhan passed away in the ICU on April 26. Since then, Ms. Cheng has held several rounds of discussions with the hospital and Immuncell regarding compensation. "We approached the hospital, and they agreed to forward our proposal to the pharmaceutical company. They said some compensation could be offered because there are regulations for this." Ms. Cheng stated that the family's proposal was subsequently not accepted. Both the hospital and the pharmaceutical company maintain a consistent position: the patient's cerebral hemorrhage was a side effect of chemotherapy drugs, unrelated to the investigational product.
During the discussions, the head of Immuncell's team verbally proposed a "humanitarian compensation" package. However, Ms. Cheng believes the term "humanitarian" itself deflects any drug-related liability. She rejected the offer and reiterated her demands: acknowledge the incident and show sincerity, rather than replacing accountability with compensation. She noted that the hospital prohibits patients from having direct contact with the pharmaceutical company. To date, only two three-party meetings convened by the hospital have taken place, after which there has been no follow-up.
Timing is critical, as Immuncell is in the midst of pursuing its Hong Kong listing. On August 18, 2026, the company resubmitted its listing application to the Hong Kong Stock Exchange main board as a pre-commercialization biotech. This is its second attempt. The IPO proceeds are mainly intended for the clinical development and commercialization of its core product IMC002, as well as research on its in vivo CAR-T platform and other pipelines.
Ms. Cheng repeatedly expressed that she cannot accept the explanations given by the hospital and Immuncell regarding her husband's sudden death during the clinical trial. She wants access to more comprehensive documentation, but the hospital says internal materials cannot be shared — only medical records are available. "They owe me an explanation. This is a serious adverse event that should be reported per regulations. Can't they give the family an answer?"