PA3-17 / PersonGen Biomedicine - LARVOL DELTA

PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Phase I Clinical Study of PA3-17 Injection in Patients with Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma (ASH 2023) - P1 | "One patient (Pt6) had a tumor mass with a diameter greater than 7cm at baseline prior CAR-T infusion but achieved CR 28 days after infusion and is in sustained remission now (Figure 1). Conclusion PA3-17 injection has shown a good safety profile and encouraging efficacy in r/r T-ALL/LBL patients, and long-term data are continuing to be collected during follow-up."

Clinical • IO biomarker • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation

PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

New P2 trial • Hematological Malignancies • Leukemia • Lymphoma • Oncology

LONG-TERM OUTCOMES OF PEBL-ENGINEERED CD7 NANOBODY CAR-T (PA3-17 INJECTION) IN RELAPSED/REFRACTORY T-ALL/LBL: PHASE I TRIAL UPDATE (EHA 2025) - P1 | "PA3-17 injection demonstrated good tolerability, profound and sustained clinical activity in heavily pretreated r/r T-ALL/LBL patients, with 50% of CR patients remaining survival or/and progression-free at 1 year."

IO biomarker • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7

[Major breakthrough] Boshengji PA3-17 injection ignites new hope for long-term survival for patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma [Google traslation] (bydrug.pharmcube.com) - "Recently, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd., together with several top domestic hematology research centers, announced the long-term follow-up data of the Phase I clinical trial of PA3-17 injection for the treatment of relapsed/refractory T-lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) in the form of a poster (PS1369) at the international authoritative academic conference EHA 2025 , bringing exciting progress to this field."

P1 data • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Clinical Outcomes of CD7 CAR-T Cell Therapy in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Patients. (PubMed, Hematol Oncol) - "CD7 CAR-T cell therapy is a promising option for R/R T-ALL/LBL patients with manageable adverse events. Moreover, CD7 CAR-T cell infusion followed by consolidation allo-HSCT in R/R T-ALL/LBL patients might play an important role in prolonging remission duration."

Clinical data • Journal • Retrospective data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Transplantation • CD7

Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases (clinicaltrials.gov) - P=N/A | N=18 | Not yet recruiting | Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

New trial • Immunology • Scleroderma • Systemic Sclerosis

Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. (ASCO 2024) - P1 | "PA3-17 injection has shown a good safety profile and encouraging efficacy in r/r T-ALL/LBL patients. RP2D has been determined and the key Phase II clinical study is about to begin."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD7

A Single-Arm, Open-Label, Pilot Trial of Autologous CD7-CAR-T Cells for CD7 Positive Relapsed and Refractory T-Lymphoblastic Leukemia/Lymphoma (ASH 2021) - P1 | "Autologous CD7 CAR-T represents a promising immunotherapy for r/r T-ALL/LBL and exhibited encouraging clinical efficacy and safety in treating r/r T-ALL/LBL and ETP-ALL/LBL."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7

CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. (PubMed, Exp Hematol Oncol) - P1/2 | "Before the CAR T-cell therapy, the patient achieved partial remission with IA regimen and attained complete remission after reinduction therapy (decitabine and venentoclax)...Then she failed CLIA regimen combined with venetoclax and exhibited resistance to FLT3 inhibitors...In summary, the autologous CD7 CAR T-cell therapy could be considered a potential approach for AML with CD7 expression (NCT04762485).Trial registration Clinical Trials.gov, NCT04762485. Registered on February 21, 2021, prospectively registered."

CAR T-Cell Therapy • IO biomarker • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Inflammation • Leukemia • Oncology • CD7 • FLT3 • RUNX1 • SKAP2 • TP53

Autologous nanobody-derived fratricide-resistant CD7-CAR T cell therapy for patients with relapsed and refractory T-cell acute lymphoblastic leukemia/lymphoma. (PubMed, Clin Cancer Res) - P1 | "Autologous nanobody-derived fratricide-resistant CD7-CAR T cells demonstrated a promising and durable antitumor response in R/R T-ALL/LBL with tolerable toxicity, warranting further studies in highly aggressive CD7-positive malignancies."

CAR T-Cell Therapy • Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7

Haploidentical CD7 CAR T-cells induced remission in a patient with TP53 mutated relapsed and refractory early T-cell precursor lymphoblastic leukemia/lymphoma. (PubMed, Biomark Res) - P=N/A | "The patient suffered second relapse after haploidentical hematopoietic stem cell transplantation, showing resistance to 4 lines salvage therapies including venetoclax. This case demonstrated that CD7-CART was a potent and safe salvage therapy in relapsed/refractory ETP-ALL/LBL patient with high tumor burden.Trial registration: ClinicalTrials. gov, NCT04785833 , Registered on March 8, 2021, prospectively registered."

CAR T-Cell Therapy • IO biomarker • Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Oncology • Transplantation • CD7 • TP53

Haplo-Identical Non-Gene Editing CD7 CAR T-Cells Induced Bone Marrow and Extramedullary Remission in a Pediatric Patient with TP53 Mutated Relapsed and Refractory Early T-Cell Precursor Lymphoblastic Leukemia/Lymphoma after Haploidentical Hematopoietic Stem Cell Transplantation (ASH 2021) - "The patient was resistant to venetoclax combined with decitabine, homoharringtonine, aclarubicin, cytarabine and granulocyte colony stimulating factor (G-CSF), high-dose cytarabine combined with cladribine, G-CSF, chidamide and CD38 CART therapy...Grade 3 cytokine release syndrome with high fever and hypotension were observed, which was relived by tocilizumab and dexamethosone. No organ dysfuction and immune effector cell-associated neurotoxicity syndrome were observed. In general, we showed for the first time that the nanobody derived CD7-CART with PEBL technology was a potent and safe salvage therapy in a relapsed/refractory ETP-ALL/LBL patient with high tumor burden."

CAR T-Cell Therapy • Clinical • IO biomarker • Bone Marrow Transplantation • Hematological Malignancies • Hypotension • Inflammation • Leukemia • Lymphoma • Oncology • Pediatrics • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • Transplantation • CD38 • CD7 • LAG3 • PD-1 • TP53

Chimeric antigen receptor T cells derived from CD7 nanobody exhibit robust antitumor potential against CD7-positive malignancies. (PubMed, Am J Cancer Res) - "Furthermore, we confirmed that the antitumor activity of CD7-CAR-T cells was positively correlated with the antigen density of tumor cells. This strategy adapts well with current clinical-grade CAR-T-cell manufacturing processes and can be rapidly applied for the therapy of patients with CD7 malignancies."

CAR T-Cell Therapy • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD7

CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: The First Affiliated Hospital of Soochow University

CAR T-Cell Therapy • New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD4 • CD7 • CD8

[VIRTUAL] A single-arm, open-label, pilot trial of Autologous CD7-CAR-T Cells for CD7 Positive Relapsed and Refractory T-lymphoblastic leukemia/lymphoma (ICML 2021) - P1 | "Autologous CD7 CAR-T is a novel immunotherapy for r/r T-ALL/LBL and exhibited encouraging clinical efficacy and safety in treating r/r T-ALL/LBL and ETP-ALL/LBL."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Lymphoma • Oncology • CD7

Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia (clinicaltrials.gov) - P1/2; N=20; Recruiting; Sponsor: The First Affiliated Hospital of Soochow University; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2021 ➔ Jun 2021

CAR T-Cell Therapy • Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD7