Status:
UNKNOWN
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
Lead Sponsor:
Zhejiang University
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.
Eligibility Criteria
Inclusion
- Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.
- Failing to autologous CAR-T therapy.
- At least one available lesion to be assessed.
- Good organ function during screening.
- Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.
Exclusion
- Allergic to preconditioning measures.
- 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.
- Uncontrollable bacterial, fungal and viral infection during screening.
- Patients had pulmonary embolism within 3 months prior to enrollment.
- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
- Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
- 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.
- Had big lesion(single lesion diameter ≥10 cm).
- Bone marrow involvement≥5%.
- Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
- Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
- Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
- 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.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05349266
Start Date
March 18 2022
End Date
April 30 2024
Last Update
April 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003