Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of subjects with CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.
Primary Endpoint: MTD, RP2D or biologically effective dose; to assess the incidence, severity and relatedness of AEs and SAEs.
Indication: CD70-positive relapsed or refractory T-cell and B-cell hematological malignancies
Prior to performing any study-related assessments/procedures, understand and voluntarily sign the Informed Consent Form (ICF)；
Age between 18 and 70 years (inclusive) at the time of signing the ICF;
Tumor cells in bone marrow or peripheral blood are CD70-positive as detected by flow cytometry; or CD70-positive by immunohistochemistry (IHC) testing of tumor tissue;
Relapsed/refractory T-cell malignancies with measurable disease defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion detected by imaging (PET-CT or CT) per Lugano criteria (lymph node lesion: any diameter >1.5 cm; extranodal lesion: any diameter >1.0 cm), and meeting the following criteria: relapsed/refractory peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, adult T-cell leukemia/lymphoma) or cutaneous T-cell lymphoma (including but not limited to mycosis fungoides or Sézary syndrome [Stage IIB or higher, disease involving two or more regions, or single-region disease with large-cell transformation]), and have received prior systemic therapy: patients with peripheral T-cell lymphoma must have received at least 1 line of therapy; patients with cutaneous T-cell lymphoma must have received at least 2 lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin-containing therapy, or relapsed after ≥2 prior lines of therapy (if anaplastic lymphoma kinase-positive)；
Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic spinal cord compression; or prior history of CNS diseases, including but not limited to seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc；
History of organ transplantation;
Cervical carcinoma in situ that has been adequately treated and cured;
Localized basal-cell carcinoma or squamous-cell carcinoma of the skin;
Single group
CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101)
Drugsingle or multiple administrations，3.6\*10\^9 CAR-T cells，7.2\*10\^9 CAR-T cells，10\*10\^9 CAR-T cells.
MTD
To assess the incidence,severity and relatedness of AEs and SAEs.
Peripheral blood CAR-T cell proportion
ORR
DOR
PFS
Click on the lead sponsor to view all of their trials.
Nanjing Miracle Biotechnology Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Nanchang University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
