Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

NCT05436223 | Recruiting Phase 2

• 1 other identifier: HRAIN01-NHL01-Ⅱ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Conditions

B-cell Non-Hodgkin's Lymphoma

Keywords

B-cell non-Hodgkin's Lymphoma; CD19; CAR-T; Relapsed/Refractory

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) at 3 months post infusion

  ORR is defined as proportion of subjects who achieved Partial remission(PR) or better at 3 months (D90±7) post infusion as assessed by an independent review committee (IRC) based on Lugano 2014 criteria.

  3 months post infusion

Secondary Outcomes (9)

• Duration of remission (DOR) after administration

  2 years post infusion

• Progression-free Survival (PFS) after administration

  2 years post infusion

• Overall Survival (OS) after administration

  2 years post infusion

• Disease control rate (DCR)

  2 years post infusion

• Safety evaluation

  2 years post infusion

Study Arms (1)

Human CD19 Targeted T Cells Injection

EXPERIMENTAL

Single administration：2.0×10\^6 CAR+T/kg

Drug: Human CD19Targeted T Cells Injection

Interventions

Human CD19Targeted T Cells Injection DRUG

A single dose of predetermined level CAR-positive T cells will be infused.

Also known as: CD19 CAR-T

Human CD19 Targeted T Cells Injection

Eligibility Criteria

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

You may qualify if:

• Age≥18 years old，gender is not limited;
• Expected survival \> 12 weeks;
• ECOG score 0-2;
• B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);
• Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
• Relapsed and refractory B-cell non-Hodgkin's lymphoma, after standard first-line treatment and at least 2 courses of second-line treatment without remission and relapse (the previous use of CD20-targeted drugs and anthracyclines were needed);
• Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments.
• The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g/L, neutrophils ≥1.0×10\^9/L, platelets ≥75×10\^9 / L;
• According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
• Serum creatinine≤1.5×ULN or creatinine clearance rate≥50mL/min (GockcroftGault formula);
• Cardiac ejection fraction \>50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected;
• Baseline blood oxygen saturation\>92%;
• Total bilirubin≤1.5×ULN(Gilbert syndrome≤5×ULN);
• ALT and AST≤3×ULN (AST and ALT ≤5×ULN in patients with liver metastases);

You may not qualify if:

• Malignant tumors other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
• Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and positive peripheral blood hepatitis B virus (HBV) DNA titers (higher than the upper limit of the normal range of the investigative site); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis positive;
• Any uncontrolled systemic diseases, including but not limited to active infection (except for localized infection), uncontrolled angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
• Any other uncontrolled active disease that precludes participation in the trial;
• Any circumstances that the investigator believes will compromise the safety of the subject or interfere with the purpose of the study;
• Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year after treatment, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
• Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment (except uncomplicated urinary tract infection or upper respiratory tract infection);
• Subjects who were receiving systemic steroid treatment within 14 days before enrollment and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use); or subjects who received any systemic anti-tumor therapy ( except for local anti-tumor therapy) ;
• Subjects who have received CAR-T treatment or other gene-modified cell therapy before enrollment;
• Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
• Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
• Subjects who are considered unsuitable to participate in this trial by the investigator.

Sponsors & Collaborators

• Hrain Biotechnology Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peng Liu, M.D. & Ph.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuedong Sun, M.D.

CONTACT

+8615811287219; sunxuedong@dashengbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: August 9, 2021
• Primary Completion: August 9, 2024
• Study Completion (Estimated): August 9, 2026
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)