CAR-T cell therapy for T-cell leukemia and lymphoma that came back or resisted treatment

Trial details

Who runs it

Peking University People's Hospital

Trial code

NCT06874946

Record updated

7 May 2026

Original description

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/NHLRead full original descriptionShow less

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

Inclusion: 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.

Exclusion: History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:; Crohn's disease; Rheumatoid arthritis; Systemic lupus erythematosus (SLE); Systemic sclerosis; Inflammatory bowel disease (IBD); Vasculitis; Psoriasis; Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment; Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator); Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study; Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0); Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg/day prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:; Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections); Systemic corticosteroids ≤10 mg/day prednisone (or equivalent physiological dose); Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT); Steroids used for symptomatic treatment of transfusion-related reactions; Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period; History of active tuberculosis infection within 1 year prior to signing the ICF, except for subjects with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of active tuberculosis; History of other primary malignancies within 5 years prior to signing the ICF, except for:; Adequately treated carcinoma in situ of the cervix; Localized basal cell carcinoma or squamous cell carcinoma of the skin; Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period; History of central nervous system (CNS) diseases, including but not limited to:; Epilepsy; Paralysis; Aphasia; Stroke; Severe brain injury; Dementia; Parkinson's disease; Neuropathy; Positive virological or infectious disease markers, including:; Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded; Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded; Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded; Cytomegalovirus (CMV) DNA test-positive subjects should be excluded; Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded; Positive serological or non-specific antibodies for Treponema pallidum (syphilis); History of severe hypersensitivity or allergy to any components of the study drug; Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation; Clinically significant cardiovascular diseases, including any of the following:; QTc interval ≥480 ms (Fridericia correction formula); New York Heart Association (NYHA) Class II or higher heart failure; Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF; Left ventricular ejection fraction (LVEF) <50%; Poorly controlled hypertension (as determined by the investigator); Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:; Persistent ventricular tachycardia; Ventricular fibrillation; Torsades de pointes; Complete left bundle branch block; Pregnancy or lactation.

ClinicalTrials.gov NCT06874946