Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of anti-CD70 chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.
Secondary Objectives: To characterize the PK profiles of CHT101; to evaluate the clinical efficacy of CHT101 for CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies.
Indication: CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies
Understand and voluntarily provide written informed consent (ICF) prior to any study-related assessments/procedures;
Aged between 18 and 70 years (inclusive) at the time of ICF signing;
CD70-positive tumor cells detected in bone marrow or peripheral blood by flow cytometry, or positive CD70 immunohistochemistry in tumor tissue;
Subjects with relapsed/refractory T-cell malignancies with measurable disease as defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion identified by imaging (PET-CT or CT) according to Lugano criteria (lymph node lesion with any diameter >1.5 cm; extranodal lesion with 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 with disease involving two or more regions, or single-region disease with large-cell transformation]), and having received prior systemic therapy: subjects with peripheral T-cell lymphoma shall have received at least one line of therapy; subjects with cutaneous T-cell lymphoma shall have received at least two lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin therapy, or relapsed after ≥2 prior therapies (if anaplastic lymphoma kinase-positive);
Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic central compression; or prior history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.;
History of organ transplantation;
History of other primary malignancies within 5 years prior to study treatment, except for: a) adequately treated and cured carcinoma in situ of the cervix; b) localized basal-cell carcinoma or squamous-cell carcinoma of the skin;
Subjects with positive HBV DNA in peripheral blood at screening; subjects positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with both positive treponemal-specific antibody and non-treponemal antibody tests for syphilis;
Single group
CHT101
DrugSingle-dose and multiple-dose administration Method of Administration: Intravenous infusion Dose of Administration:3.6\*10\^9 CAR-T cells,7.2\*10\^9 CAR-T cells,10\*10\^9 CAR-T cells.
Maximum tolerated dose (MTD)
To assess the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs).
Peripheral blood CAR-T cell proportion
ORR
DOR
PFS
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Nanjing Miracle Biotechnology Co., Ltd.
Lead sponsor
Jiangxi Provincial Cancer Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
