LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

Exclusion Criteria

• •1. Prior treatment with CAR-T therapy directed at any target.
• •2. Any therapy that is targeted to CD4.
• •3. Prior treatment with an allogeneic stem cell transplant
• •4. Any malignancy besides the T lymphocyte tumor categories under study, exceptions include
• •1. Any other malignancy curatively treated and disease-free for at least 2 years prior to enrollment
• •2. History of non-melanoma skin cancer with sufficient treatment and currently no evidence of recurrence
• •5. Those who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab)
• •6. The following cardiac conditions:
• •1. New York Heart Association (NYHA) stage III or IV congestive heart failure
• •2. Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment
• •3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
• •4. History of severe non-ischemic cardiomyopathy
• •5. Impaired cardiac function (LVEF \<45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis)
• •7. Prior antitumor therapy as follows, prior to apheresis:
• •1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less.
• •2. Monoclonal antibody treatment for multiple myeloma within 21 days.
• •3. Cytotoxic therapy within 14 days.
• •4. Radiotherapy within 14 days.
• •5. Participated in other clinical trials within 30 days.
• •8. Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
• •9. With central nervous system involvement.
• •10. Serious underlying medical condition, such as:
• •1. Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
• •2. Active or unstable autoimmune diseases or autoimmune diseases that have been suffered within 3 years and have the possibility of recurrence
• •3. Overt clinical evidence of dementia or altered mental status
• •11. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 100 days after receiving study treatment.
• •12. Plans to father a child while enrolled in this study or within 100 days after receiving study treatment.
• •13. With obvious hemorrhagic tendency such as gastrointestinal hemorrhage, coagulation disorders and hypersplenism
• •14. Oxygen is needed to maintain sufficient blood oxygen saturation(≥95%)
• •15. Suffer from chronic diseases that require treatment with systemic corticosteroids or other immunosuppressive agents ,Received a cumulative dose of corticosteroids equivalent to ≥20 mg/day of prednisone within 7 days prior to apheresis
• •16. CNS diseases with clinical significance in the past or at the time of screening
• •17. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis
• •18. Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study or within 2 weeks after study treatment administration. (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.)
• •19. Known life threatening allergies, hypersensitivity, or intolerance to LCAR-T2C CAR-T cells or its excipients, including DMSO (refer to Investigator's Brochure)
• •20. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol