Recently, RocRock Bio's independently developed third-generation chimeric antigen receptor macrophage (CAR-M) drug, RR-M01 injection, completed the first clinical trial participant's dosing at the Affiliated Hospital of Xuzhou Medical University. After a month-long inpatient observation, the participant was discharged smoothly. This clinical trial launch brings new hope to the treatment of malignant solid tumors, especially recurrent and refractory ovarian cancer.
Ovarian cancer is a common gynecological malignancy, with an incidence ranking third among female reproductive tract malignant tumors but the highest mortality rate. Despite improvements in surgical skills and the clinical application of taxane, platinum, and other targeted drugs over the past 20 years, which have significantly improved the prognosis of ovarian cancer patients, the 5-year survival rate for advanced patients is still less than 30%. Thus, finding new effective drugs is urgent to achieve better therapeutic effects.
RR-M01 injection is a third-generation CAR-M cell therapy drug for HER2-positive solid tumors. RocRock Bio and the Affiliated Hospital of Xuzhou Medical University initiated an Investigator Initiated Trial (IIT) in 2023 to evaluate the safety and efficacy of CAR-M cell therapy for recurrent and refractory ovarian cancer with high HER2 expression.
The first participant was a 65-year-old woman with a 2-year history of ovarian malignant tumor. She underwent surgery to remove her ovaries and uterus and was treated with multiple first-line regimens. However, one year after surgery, she still had multiple metastases, and pathological testing showed HER2++. She was screened and enrolled in December 2023, and in the same month, she completed blood collection, CAR-M preparation and quality control, and cell reinfusion treatment. After the operation, the participant's vital signs were stable, she felt comfortable, and her general condition was good. Throughout the follow-up observation period, no serious adverse reactions occurred, indicating good safety of the cell drug. Meanwhile, the participant's clinical symptoms gradually improved compared to before treatment, and tumor markers and other indicators were effectively controlled. After discharge, the patient will continue to follow up regularly according to the clinical plan.
Dr. Xiushan Yin, CEO of RocRock Bio, stated: "CAR-M is a highly promising targeted immunotherapy for solid tumors. Using non-integrating viral vectors to transduce macrophages does not pose a risk of secondary carcinogenesis. During treatment, lymphodepletion is not required, which greatly benefits patients. Additionally, since other immune cells are not eliminated, they can work synergistically to enhance efficacy. RocRock Bio is a biotechnology company focused on developing macrophage drugs targeting solid tumors and is currently among the international leaders. The smooth discharge of the first participant marks the official entry of RocRock Bio's pipeline development into the clinical stage. We would like to thank all RocRock employees for their hard work, the team led by Director Chen Buzze from the Affiliated Hospital of Xuzhou Medical University, and our strategic partner, Jiangsu Jicai Juchuang Bio-technology Research Institute Co., Ltd. (the Cell Therapy Drug Clinical Research Center of the National Technology Innovation Center for Bio-drugs) for their strong support. RocRock Bio will accelerate the registration of clinical trials for this pipeline to benefit more cancer patients as soon as possible."
Director Chen Buzze from the Affiliated Hospital of Xuzhou Medical University, the principal investigator of this clinical study, said: "This participant showed very stable conditions after dosing, and tumor markers and other indicators were effectively controlled. This indicates that RR-M01 has good safety and potential efficacy for recurrent and refractory ovarian cancer, bringing great confidence to the entire clinical research team. Next, we will actively carry out dose-escalation and expanded-indication clinical studies. At the same time, we would like to thank the participants, their families, and their clinical and nursing staff, as well as all researchers, for their efforts in advancing ovarian cancer research."
Chimeric antigen receptor macrophage (CAR-M) represents a novel immunotherapy approach. First-generation CAR-M cells utilized the CD3ζ domain. The second generation incorporated macrophage-specific domains, boosting phagocytosis and tumor-killing capabilities. RocRock Bio's third-generation CAR-M, conceptualized since 2010, builds on the existing CAR by adding cytokines crucial for macrophage self-proliferation and activation. This enhances in-vivo survival, alters the tumor microenvironment, and further improves phagocytosis, tumor-killing, and antigen presentation. RocRock Bio's third-generation CAR-M is fully self-developed and domesticated. Recognized as a national disruptive technology in 2021, it was approved for a national "Revealing the List and Leading the Way" project in 2023, signifying major strategic importance.
The RR-M01 pipeline, developed by RocRock Bio, is a cutting-edge third-generation CAR-M therapy targeting HER2-positive solid tumors. It offers a promising treatment option for recurrent and refractory cancers like ovarian, stomach, breast, cervical, endometrial, lung, and pancreatic cancers. Thanks to its safety, innovation, and maturity, RR-M01 became the first third-generation CAR-M drug to enter the Investigator Initiated Trial (IIT) stage globally in 2023.
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