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

Zhejiang University

Status and phase: Unknown; Phase 1

Conditions: Non-Hodgkin's Lymphoma

Treatments: Biological: ThisCART19A

Study type: Interventional

Funder types: Other

Identifiers

NCT05349266

FT400-003

Details and patient eligibility

About

This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: ThisCART19A

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

Experimental group

Description:

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

Treatment:

Biological: ThisCART19A

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

Experimental group

Description:

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

Treatment:

Biological: ThisCART19A