ThisCART19A for B-NHL Relapsed After Auto-CAR T

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ThisCART19A for patients who have B-cell non-Hodgkin lymphoma that has come back after being treated with another CAR T-cell therapy. The goal is to see how effective and safe this new treatment is, as well as how it behaves in the body. This is a phase 1 trial, which means it’s one of the first steps in testing this therapy in humans, and it is currently looking for participants aged between 18 and 75 who have specific types of lymphoma and meet certain health criteria.

To be eligible for the trial, patients need to have confirmed relapsed B-cell non-Hodgkin lymphoma and be in reasonably good health, with a life expectancy of at least 12 weeks. They should also have measurable cancer lesions and meet specific requirements for blood and organ function. If you or someone you know is considering participation, it’s important to discuss any existing health conditions, as there are some exclusions, such as active infections or other serious health issues. Participants will receive the new treatment and will be closely monitored throughout the study to track its effects and any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign a documented IRB-approved ICF prior to any screening procedure;
• • 2. Gender not restricted, 18 years ≤ age ≤ 75 years;
• • 3. Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma;
• • 4. Life expectancy ≥ 12 weeks at the time of enrollment;
• • 5. Eastern Cooperative Oncology Group performance status score of 0 or 1;
• • 6. At least one measurable lesion to be assessed, with any nodal lesion \> 15mm in LDi (longest diameter) and any extranodal lesion \> 10mm in LDi;
• 7. Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
• • 1. Adequate marrow function for lymphodepletion chemotherapy: 14 days before enrollment, absolute neutrophil count (ANC) ≥ 1×10\^9/L, platelet count ≥ 30×10\^9/L, hemoglobin ≥ 80 g/L without blood transfusion;
• • 2. Creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN), total bilirubin ≤ 2×ULN (Subjects with Gilbert syndrome or liver involvement may be enrolled if their total bilirubin is ≤ 3×ULN);
• • 3. Pulmonary function: Baseline oxygen saturation (SaO2) ≥ 92% on room air;
• • 4. Cardiac function：left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
• • 8. CD19-positive lymphoma confirmed on a biopsy during screening.
• Exclusion Criteria:
• • 1. Allergic to preconditioning measures in the trial.
• • 2. Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.)
• • 3. Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted).
• • 4. Pulmonary embolism (PE) within 3 months prior to enrollment.
• • 5. Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment.
• • 6. Gastrointestinal involvement at risk of active bleeding.
• • 7. Massive pericardial effusion, symptomatic thoracic or abdominal effusion.
• • 8. Presence of CNS involvement (both primary and secondary) at screening confirmed by imaging or CSF testing.
• • 9. Active hepatitis B virus (serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Patients with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.)
• • 10. Less than 100 days after allogeneic hematopoietic stem cell transplantation.
• • 11. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Patients vaccinated with SARS-COV19 vaccine or inactivated; live/non-live adjuvant vaccines can be enrolled.)
• • 12. Under treatment for graft versus host disease (GvHD). (GvHD cured subjects who had stopped immunosuppressive drugs for at least 1 month can be enrolled.)
• • 13. Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion;
• • 14. Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.