First disclosure of data from Phase 1 study of the donor-derived allogeneic CAR-T GC007g shows 100% overall response rate (ORR) and a favorable safety profile for treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
Longer-term GC012F data in relapsed/refractory multiple myeloma (RRMM) and B-cell non-Hodgkin's lymphoma (B-NHL) indications to be highlighted, with B-NHL data selected for oral presentation
A third abstract highlights first clinical data from a Phase 1 trial evaluating GC007g, a CD19-targeted donor-derived allogeneic CAR-T cell therapy, in patients with r/r B-ALL who relapsed after receiving allogeneic stem cell transplant (allo-HSCT). The data showcases a 100% ORR and will be presented on
"We are pleased to have our FasTCAR-T GC012F data in B-NHL selected for an oral presentation, and look forward to presenting additional data in the RRMM indication, as well as from our donor-derived CAR-T candidate for r/r B-ALL, at this year's
CD19-Targeted Donor-Derived Allogeneic GC007g for the Treatment of r/r B-ALL
GC007g is a donor-derived CAR-T candidate that 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.
Between
At day 28 after infusion, 100% patients achieved minimal residual disease negative complete remission with/without incomplete count recovery (MRD- CR/CRi). At a median follow-up of 445 days (range 218-649 days), seven of nine patients remained in CR/CRi, while two patients had CD19 negative relapse. The ORR was 100% (7/7), 85.7% (6/7) and 50% (2/4) at month 3, 6, and 12, respectively. The 1-year progression-free survival (PFS) and overall survival (OS) were 76.2% and 85.7%, respectively.
Cytokine release syndrome (CRS) is presented as Grade 1 to Grade 3 events, with no Grade 4 or 5 events, and all resolved after treatment. No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Three patients were observed to have acute graft-versus-host disease (aGvHD) and all cases resolved after standard-of-care treatment. No chronic graft-versus-host disease (cGvHD) occurred.
The Phase 2 clinical trial of GC007g is currently recruiting patients in
Results will be detailed in a poster presentation, which will be available to registered attendees on the EHA website.
Details of Gracell's GC007g poster presentation are as follows:
Additional Presentations for BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of B-NHL and RRMM
Gracell will also present updated results from two studies evaluating its investigational BCMA/CD19 dual-targeting FasTCAR-T GC012F candidate in B-NHL (as an oral abstract) and in RRMM (as a poster). These data are currently under embargo and will publish on
Details of the GC012F oral presentation in B-NHL are as follows:
Details of the GC012F poster presentation in RRMM are as follows:
For more information about the
About GC007g
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 suitable for autologous CAR-T therapy.
About GC012F
GC012F is Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer treatment by driving fast, deep and durable responses with improved safety profile. GC102F is currently being evaluated in investigator-initiated trials in multiple myeloma and B-cell non-Hodgkin's lymphoma (B-NHL), and has demonstrated a consistently strong efficacy and safety profile. In
About FasTCAR
Introduced in 2017, FasTCAR is Gracell's revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of cancer therapy and improve outcomes for patients by enhancing efficacy, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger and are more enhanced than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In
About B-ALL
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 6,540 new cases to be diagnosed in
About Gracell
Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell and gene therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CARTM 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 on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.
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