Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

Launched by HENAN CANCER HOSPITAL · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ThisCART19, which is a type of therapy designed to help adult patients with certain blood cancers, specifically B cell malignancies, who have not had success with previous treatments that use their own immune cells (known as autologous CAR-T therapy). The goal of the study is to see how safe and effective ThisCART19 is for these patients. To join the trial, participants need to be between 14 and 75 years old, have a specific type of cancer that is still detectable, and must have already tried and not responded to the previous CAR-T therapy.

If someone qualifies for this trial, they will receive ThisCART19 and will be monitored closely for any side effects and to see if their condition improves. The study is currently not recruiting participants, but it's important to know that potential participants should not have other major health issues or infections and should not be pregnant or planning to become pregnant shortly after the treatment. This trial is a step towards finding new options for patients with challenging blood cancers, and those who are interested should speak with their doctor for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；
• • 2. No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；
• • 3. Failing to autologous CAR-T therapy；
• • 4. Should be confirmed Cluster of differentiation(CD)19 positive；
• • 5. The expected survival time is ≥12 weeks;
• • 6. ECOG score 0-1;
• • 7. Measurable or detectble disease at time of enrollment.
• • 8. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；
• Exclusion Criteria:
• • 1. Allergic to preconditioning measures；
• • 2. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients 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. Uncontrollable bacterial, fungal and viral infection during screening；
• • 4. Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
• • 5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；
• • 6. The presence of central nervous system involvement；
• • 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；
• • 8. Had big lesion(single lesion diameter ≥10 cm)；
• • 9. Receive allogeneic hematopoietic stem cell transplantation less than 100 days；
• • 10. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)；
• • 11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；
• • 12. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.