Gracell Biotechnologies Doses First Patient in Phase 2 Portion of Registrational Phase 1/2 Clinical Trial Evaluating Treatment of B-cell Acute Lymphoblastic Leukemia

Gracell Biotechnologies Inc. recently announced the first patient has been dosed in the Phase 2 portion of its registrational Phase 1/2 clinical trial evaluating GC007g for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) being conducted in China.

GC007g is Gracell’s allogeneic, human leukocyte antigen (HLA)-matched, donor-derived, CD19-directed CAR-T cell therapy candidate under development for the treatment of a subset of B-ALL patients who relapsed after allogeneic human stem cell transplant (allo-HSCT). This donor-derived CAR-T approach has been designed for r/r B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other unsuitable conditions.

Data from the Phase 1 trial showed encouraging efficacy and a favorable safety profile. The registrational Phase 2 trial is being conducted in China and will further assess the safety and efficacy of GC007g in r/r B-ALL patients at the recommended Phase 2 dose.

“B-ALL patients that relapse after allo-HSCT therapy often face poor prognoses, and remain a patient population with a clear unmet medical need. Donor-derived CAR-T therapy could provide a new option to some of these patients who might be ineligible for other treatments including autologous CAR-T therapy,” said Dr. Wendy Li, Chief Medical Officer of Gracell. “We believe GC007g is a potential first-in-class donor-derived allogeneic CAR-T therapy in China. GC007g is also Gracell’s first therapeutic candidate to enter a registrational trial, marking an important milestone in our quest to transform cell therapy.”

GC007g is an allogeneic CD19-targeted CAR-T cell therapy, derived from HLA-matched donors, under development for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy.

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the US in 2022. B-ALL accounts for 75% of ALL diagnoses in adults.

Gracell Biotechnologies Inc. is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CART technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information, visit www.gracellbio.com.