A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL/NHL): The CONQUER Trial
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL
• The subject or guardian understands and voluntarily signs the informed consent form (ICF).
• Male or female, aged 3-70 years at the time of signing the ICF (inclusive).
• Expected survival of at least 12 weeks.
• ECOG performance status of 0-2 at the time of ICF signing.
• Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia/lymphoma (R/R T-ALL/NHL) confirmed at screening and meeting at least one of the following criteria:
∙ Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and/or
‣ Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and/or
‣ Extramedullary disease: Presence of measurable lesions (lymph node/mass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).
‣ CD5 expression: Tumor cells in bone marrow, peripheral blood, or CSF are CD5-positive by flow cytometry, and/or lymph node/mass or extranodal lesions are CD5-positive by pathology.
• Adequate major organ function, defined as:
∙ AST and ALT ≤5× upper limit of normal (ULN).
‣ Total bilirubin ≤2× ULN.
‣ Renal function: Serum creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5× ULN.
• Blood oxygen saturation \>92%.
• Reproductive health requirements:
‣ Fertile men and women of childbearing potential must agree to use effective contraception from ICF signing until 2 years after study drug administration.
⁃ Women of childbearing potential (pre-menopausal or within 2 years post-menopause) must have a negative blood pregnancy test at screening.