Anaplastic Large Cell Lymphoma Clinical Trials

• Subjects must provide written informed consent and demonstrate good compliance with study procedures.

• Age between 18 and 70 years, inclusive; male or female.

• Histologically confirmed relapsed or refractory lymphoma (with priority for Hodgkin lymphoma, anaplastic large cell lymphoma, or other lymphoproliferative disorders), with CD30 expression confirmed by immunohistochemistry or flow cytometry (≥50% positive cells).

• Relapsed or refractory disease, defined as:

‣ \*\*Hodgkin Lymphoma (HL):\*\*

• Failure to achieve remission or disease progression after autologous hematopoietic stem cell transplantation (auto-HSCT); OR

∙ Failure of at least two prior lines of systemic chemotherapy; OR

∙ Ineligibility for auto-HSCT due to:

‣ Chemotherapy resistance (failure to achieve CR or PR after salvage chemotherapy);

⁃ Failed stem cell collection, or investigator-assessed inability to collect, or severe comorbidities, or patient refusal of auto-SCT.

⁃ \*\*Anaplastic Large Cell Lymphoma (ALCL):\*\* Failure of at least two prior lines of systemic chemotherapy or relapse after response.

⁃ \*\*Other CD30+ lymphomas:\*\* No standard treatment options available, or failure after standard therapy.

• At least one evaluable lesion according to the Lugano Classification for Malignant Lymphomas (Cheson 2014).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.

• Adequate bone marrow reserve at screening:

‣ Absolute lymphocyte count (ALC) ≥ 0.3 × 10⁹/L;

⁃ Platelet count (PLT) ≥ 30 × 10⁹/L (transfusion-supported values are acceptable).

• Adequate organ function, defined as:

‣ Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);

⁃ Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN if due to tumor infiltration);

⁃ Total serum bilirubin ≤ 2 × ULN, except for Gilbert's syndrome (total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN);

⁃ Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula);

⁃ No more than grade 1 dyspnea, and oxygen saturation \> 91% on room air;

⁃ Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiogram;

⁃ International Normalized Ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

• Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to CAR-T infusion. All sexually active males and females of childbearing potential must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.

⁃ Adequate venous access for leukapheresis or blood collection, and no contraindications to leukapheresis.

⁃ Expected survival of at least 3 months.