GC007G / AstraZeneca - LARVOL DELTA

CD-19 CAR-T cell therapy in adult B-cell ALL patients: A systematic review of clinical trials. (ASCO 2025) - "CD19 CAR-T cell therapies, including Obe-cel, KTE-X19, UCART19, and GC007g, have demonstrated efficacy and safety in the treatment of relapsed/refractory (RR) adult B-cell ALL patients. Among these, Obe-cel stands out with a lower incidence of severe cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), making it a promising therapy for outpatient administration. However, large-scale, randomized, multi-center clinical trials are essential to validate these findings and further refine the role of CD19 CAR-T therapies in this high-risk population."

CAR T-Cell Therapy • Clinical • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or refractory B-cell acute lymphoblastic leukemia after allogeneic HSCT: a phase 1 trial. (PubMed, EClinicalMedicine) - P1 | "GC007g expanded and induced durable remission in patients with B-ALL relapsed after allo-HSCT, with manageable safety profiles. Gracell Biotechnologies Inc."

CAR T-Cell Therapy • Journal • P1 data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Leukemia • Oncology • Transplantation • ABL1 • BCR

Gracell Biotechnologies Reports Third Quarter 2023 Unaudited Financial Results and Provides Corporate Update (GlobeNewswire) - "Gracell Biotechnologies Inc...today reported third quarter unaudited financial results for the period ended September 30, 2023, and provided corporate updates...the Company suspended the Phase 2 trial evaluating GC007g, HLA-matched donor-derived allogeneic CD19-targeted CAR-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia."

Trial suspension • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

DONOR-DERIVED ANTI-CD19 CHIMERIC ANTIGEN RECEPTOR T CELLS FOR B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE 1 TRIAL (EHA 2023) - P1 | "Donor-derived CD19 CAR T-cell expanded and induced durable remission in patients with B-ALL relapsed after allo-HSCT, with manageable safety profiles. Phase 2 clinical trial of GC007g is currently recruiting. B cell acute lymphoblastic leukemia, CAR-T"

CAR T-Cell Therapy • IO biomarker • P1 data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Leukemia • Oncology • Transplantation • ABL1 • BCR • CD19

Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-Targeting FasTCAR-T GC012F in RRMM and B-NHL and Donor-Derived CAR-T GC007g in B-ALL at EHA2023 Congress (PRNewswire) - "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).....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."

P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Gracell Biotechnologies Doses First Patient in Phase 2 Portion of Registrational Phase 1/2 Clinical Trial Evaluating GC007g for Treatment of B-cell Acute Lymphoblastic Leukemia (PRNewswire) - "Gracell Biotechnologies...announced that 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....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."

Trial status • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Gracell Biotechnologies Reports Second Quarter 2022 Unaudited Financial Results and Provides Corporate Update (GlobeNewswire) - "Donor-derived CAR GC007g: Completed the Phase 1 portion of the registrational Phase 1/2 clinical trial underway under a China IND for the treatment of r/r B-ALL. On track to commence Phase 2 portion in the third quarter 2022."

Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Gracell Biotechnologies Reports Third Quarter 2021 Unaudited Financial Results and Provides Corporate Update (GlobeNewswire) - "We continue advancing with the tech transfer to Lonza to support manufacturing of GC012F in the U.S., an instrumental step towards our US IND filing targeting the first half of 2022....Our donor-derived allogeneic CD19-targeted CAR-T for B-ALL, GC007g, is currently being advanced to the second dose cohort in our pivotal IND Phase 1/2 study in China.'"

IND • Non-US regulatory • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy for the Treatment of Relapsed or Refractory B-ALL (PRNewswire) - “Gracell Biotechnologies…announced that they have enrolled the first patient in their pivotal Phase 1/2 clinical study of GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia (B-ALL)…The open-label, single-arm Phase 1/2 study is evaluating the safety and efficacy of GC007g in r/r B-ALL patients.”

Enrollment status • Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

China NMPA Grants Approval for the Registrational Phase 1/2 Clinical Study for GC007g - an Allogeneic CAR-T Cell Therapy for the Treatment of Relapsed or Refractory B-ALL (PRNewswire) - "Gracell Biotechnologies Inc...has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China's National Medical Products Administration (NMPA) on December 24, 2020."

Non-US regulatory • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

Gracell announces China NMPA acceptance of investigational New Drug Application for GC007g cell therapy for CD19 positive relapsed or refractory B-cell acute lymphoblastic leukemia (PRNewswire) - "Gracell Biotechnologies Co., Ltd...is pleased to announce that China National Medical Products Administration (NMPA) has accepted Gracell's Investigational New Drug (IND) application for GC007g, a donor-derived anti-CD19 chimeric antigen receptor (CAR-T) cell therapy....The company plans to initiate a phase 1 clinical study in patients with CD19 positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) in Q2, 2020."

New P1 trial • Non-US regulatory

"#Gracell Announces China #MNPA Acceptance of #InvestigationalNewDrugApplication for #GC007g #CellTherapy for #CD19 Positive Relapsed or Refrctory #BCellAcuteLymphoblasticLeukemia https://t.co/18qUsE1g6L" (@1stOncology)

IND