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

NCT05349266 | Unknown Phase 1

• 1 other identifier: FT400-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage

  DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

  28 days

• Objective Response Rate in patient with NHL during dose expansion stage

  the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment

  12 months

Secondary Outcomes (8)

• Objective Response Rate during dose escalation stage and expansion stage

  12 months

• Duration of response(DOR) during dose escalation stage and expansion stage

  12 months

• OS(overall survival) during dose escalation stage and expansion stage

  12 months

• Time to remission(TTR) during dose escalation stage and expansion stage

  12 months

• Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages

  6 months

Study Arms (3)

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

EXPERIMENTAL

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

Biological: ThisCART19A

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

EXPERIMENTAL

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

Biological: ThisCART19A

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

EXPERIMENTAL

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

Biological: ThisCART19A

Interventions

ThisCART19A 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; ThisCART19A 2×10^6 cells/kg for dose level 1; ThisCART19A 3×10^6 cells/kg as dose level 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) .
• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, Doctor

  First hospital affiliated Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Ming Zhang, Doctor

CONTACT

13656674208; mingmingzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President/Proffessor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 27, 2022
• Study Start: March 18, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CN (1)