A Clinical Study to Explore CT1195E in Patients With Relapsed/Refractory B-Cell Neoplasms

Exclusion Criteria

• •1. Pregnant or lactating females;
• •2. Study participants with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
• •3. Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
• •4. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis study participants (as judged by the investigator);
• •5. Known or suspected long-term active EBV infection, known history of HLH;
• •6. The toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE 5.0) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;
• •7. Received autologous stem cell transplantation within 12 weeks before signing the informed consent form; Received allogeneic stem cell transplantation;
• •8. Prior treatment targeting CD19 (unless the CD19 or CD20 target remains positive);
• •9. Antineoplastic therapy, including but not limited to cytotoxic therapy, monoclonal antibodies or antibody conjugates, targeted therapy, radiotherapy, epigenetic therapy, or investigational drug therapy, or use of an invasive investigational medical device within 14 days or 5 half-lives (whichever is shorter) prior to cell infusion. Participants are eligible for the study regardless of the end date of radiotherapy if the radiation field covers ≤ 5% bone marrow reserve;
• •10. Systemic corticosteroids equivalent to \> 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical corticosteroids;
• •11. Vaccination with live attenuated vaccines, inactivated vaccines or RNA vaccines within 4 weeks prior to signing the informed consent form;
• •12. Allergy or intolerance to CLD drugs, tocilizumab, or allergy to the components of CT1195E cell infusion preparation (dimethyl sulfoxide/DMSO); Or previous history of other severe allergies such as anaphylactic shock;
• •13. Study participants with any of the following cardiac conditions:
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• •1. New York Heart Association (NYHA) Class III or IV heart failure;
• •2. Myocardial infarction, coronary artery bypass grafting, or unstable angina 6 months prior to screening;
• •3. History of clinically significant uncontrolled arrhythmia, such as ventricular arrhythmia;
• •4. History of severe non-ischemic cardiomyopathy;
• •5. Other cardiac disease that, in the opinion of the investigator, may jeopardize the health of the study participant due to participation in this clinical study; 14. Have other severe pulmonary disease that may endanger the life of the study participant as judged by the investigator; 15. Have a second primary malignancy requiring treatment or not in complete remission within the past 2 years, with the exception of successfully treated non-metastatic basal cell or squamous cell skin cancer, non-metastatic carcinoma in situ of the prostate, breast or cervical cancer, non-muscle invasive bladder cancer or thyroid cancer and other low-grade tumors; 16. Major surgery within 2 weeks before signing the informed consent form, or planning to undergo major surgery during the study or within 4 weeks after the administration of study treatment (excluding cataract and other surgery under local anesthesia); 17. Inability or unwillingness of the participant to comply with the requirements of the study protocol as assessed by the investigator, or for other reasons unsuitable for participation in this clinical study.
• •1. Pregnant or lactating females;
• •2. Study participants with a history of neurological disorders, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or active central nervous system (CNS) leukemia;
• •3. Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
• •4. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis study participants (as judged by the investigator);
• •5. Known or suspected long-term active EBV infection, known history of HLH;
• •6. The toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE V5.0) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;
• •7. Study participants with solitary extramedullary lesions; Study participants with genetic syndromes associated with bone marrow failure states: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
• •8. Study participants who relapsed after treatment with drugs targeting CD19 and/or CD20 prior to screening and who are judged not to benefit by the investigator;
• •9. Received autologous or allogeneic stem cell transplantation within 3 months before signing the informed consent form; Donor lymphocyte infusion (DLI) within 6 weeks;
• •10. Active graft-versus-host disease (GVHD) of grade 2-4 within 4 weeks before signing the informed consent form;
• •11. Antineoplastic therapy, including but not limited to cytotoxic therapy, monoclonal antibodies or antibody conjugates, targeted therapy, radiotherapy, epigenetic therapy, or investigational drug therapy, or use of an invasive investigational medical device within 14 days or 5 half-lives (whichever is shorter) prior to cell infusion. Participants are eligible for the study regardless of the end date of radiotherapy if the radiation field covers ≤ 5% bone marrow reserve;
• •12. Systemic corticosteroids equivalent to \> 15 mg/day prednisone within 3 days prior to cell infusion, except for topical corticosteroids;
• •13. Vaccination with live attenuated vaccines, inactivated vaccines or RNA vaccines within 4 weeks prior to signing the informed consent form;
• •14. Allergy or intolerance to CLD drugs, tocilizumab, or allergy to the components of CT1195E cell infusion preparation (dimethyl sulfoxide/DMSO); Or previous history of other severe allergies such as anaphylactic shock;
• •15. Study participants with any of the following cardiac conditions:
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• •1. New York Heart Association (NYHA) Class III or IV heart failure;
• •2. Myocardial infarction, coronary artery bypass grafting, or unstable angina 6 months prior to screening;
• •3. History of clinically significant uncontrolled arrhythmia, such as ventricular arrhythmia;
• •4. History of severe non-ischemic cardiomyopathy;
• •5. Other cardiac disease that, in the opinion of the investigator, may jeopardize the health of the study participant due to participation in this clinical study; 16. Have other severe pulmonary disease that may endanger the life of the study participant as judged by the investigator; 17. Have a second primary malignancy requiring treatment or not in complete remission within the past 2 years, with the exception of successfully treated non-metastatic basal cell or squamous cell skin cancer, non-metastatic carcinoma in situ of the prostate, breast or cervical cancer, non-muscle invasive bladder cancer or thyroid cancer and other low-grade tumors; 18. Major surgery within 2 weeks before signing the informed consent form, or planning to undergo major surgery during the study or within 4 weeks after the administration of study treatment (excluding cataract and other surgery under local anesthesia); 19. After organ transplantation; 20. Inability or unwillingness of the participant to comply with the requirements of the study protocol as assessed by the investigator, or for other reasons unsuitable for participation in this clinical study.