China-based Gracell Biotechnologies Inc. has announced the first patient dosing in the Phase II portion of its registrational Phase I/II clinical study assessing GC007g for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. This milestone marks a significant step forward in the development of innovative treatments for this challenging form of leukemia.
Clinical Study Details
GC007g was approved for a Phase I/II clinical study in China in December 2020. The Phase II portion is designed to assess the efficacy and safety of the drug in r/r B-ALL patients at the recommended dosage. The results from this study will be used to support the marketing of the product. The Phase I/II study aims to provide comprehensive data on the therapeutic potential of GC007g in treating patients who have relapsed after allogeneic human stem cell transplant (allo-HSCT).
GC007g: Donor-Derived CAR-T Therapy
GC007g is Gracell’s allogeneic, human leukocyte antigen (HLA)-matched, donor-derived, CD19-directed chimeric antigen receptor (CAR)-T cell therapy candidate. It is being developed for the treatment of a subset of B-ALL patients who relapse after allo-HSCT. This donor-derived CAR-T approach is designed for patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other unsuitable conditions. GC007g is Gracell Bio’s first drug candidate to enter a regulatory clinical study.
Unmet Medical Needs and Future Outlook
Patients with B-ALL who relapse after allo-HSCT often face poor prognoses and represent a patient population with significant unmet medical needs. The donor-derived CAR-T therapy could provide a new treatment option for some of these patients who might be ineligible for other treatments, including autologous CAR-T therapy. The initiation of the Phase II portion of the clinical study underscores Gracell Biotechnologies’ commitment to addressing these challenges and advancing innovative solutions in oncology.-Fineline Info & Tech
