PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

Korábbi kezelés

• Subjects who have received CAR-T therapy or other gene-modified cell therapy before screening;
• Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs);

Más betegség

• Known to have active or uncontrolled autoimmune diseases;
• History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ of the breast after radical surgery;
• Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
• Severe heart disease;
• Unstable systemic diseases as judged by the investigator;
• Presence of active infection or uncontrollable infection requiring systemic treatment;

Egyéb

• Presence of GvHD;
• Pregnant or breastfeeding women, and female subjects planning to conceive within 2 years after cell infusion, or male subjects whose partners plan to conceive within 2 years after cell infusion;
• Evidence of central nervous system involvement at the time of subject screening;
• Situations judged by the investigator as not suitable for cell preparation;
• Other circumstances deemed unsuitable for enrollment by the investigator.

• Age and Gender: ≥18 years old (inclusive), regardless of gender.
• Survival Expectancy: ≥3 months.
• Performance Status: ECOG score 0-1.
• Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP).
• Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
• Screening: Abnormal cells CD7 expression positive.
• Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions.
• Meet the requirements of liver, kidney, heart, and lung functions.
• No Severe Mental Disorders.
• Informed Consent: Ability to understand the trial and signed informed consent form.