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

NCT ID: NCT05349266

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2024-04-30

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ThisCART19A 2×10^6 cells/kg for dose level 1

Patients will receive 2×10\^6 cells/kg of ThisCART19A

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

each patient will receive a dose level per body weight(kg) for only once.

ThisCART19A 3×10^6 cells/kg as dose level 2

Patients will receive 3×10\^6 cells/kg of ThisCART19A

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

each patient will receive a dose level per body weight(kg) for only once.

Patients will receive 4×10^6 cells/kg as dose level 3

Patients will receive 4×10\^6 cells/kg of ThisCART19A

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

each patient will receive a dose level per body weight(kg) for only once.

Interventions

ThisCART19A

each patient will receive a dose level per body weight(kg) for only once.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

President/Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

First hospital affiliated Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Ming Zhang, Doctor

Role: CONTACT

mingmingzhang@zju.edu.cn

13656674208

Facility Contacts

He Huang, Doctor

Role: primary

hehuangyu@126.com

86-13605714822

Other Identifiers

FT400-003

Identifier Type: -

Identifier Source: org_study_id