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Trial Title: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT ID: NCT06295549

Condition: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: LUCAR-G39P cells product
Description: LUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
Arm group label: Experimental: LUCAR-G39P cells product

Summary: A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

Detailed description: his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. 2. Aged 18-75 years (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20. 5. At least one evaluable tumor lesion according to Lugano 2014 criteria. Response to prior therapy is consistent with one of the following: 1. Primary refractory. 2. Relapsed or refractory after 2 or more lines of therapy. 3. For LBCL, 3B FL. t-iNHL: - Relapse within 12 months after first-line chemoimmunotherapy to achieve CR; - Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation; 7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria Exclusion Criteria: Subject eligible for this study must not meet any of the following criteria: 1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab). 6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO. 7. Pregnant or lactating women; -

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Address:
City: Nanjin
Zip: 210029
Country: China

Status: Recruiting

Contact:
Last name: Huayuan Zhu, PhD,MD

Phone: 86 25 68306034
Email: huayuan.zhu@hotmail.com

Contact backup:
Last name: Yeqin Sha, MD
Email: yeqinsha@njmu.edu.cn

Facility:
Name: Affiliated Hospital of Nantong University

Address:
City: Nantong
Zip: 226001
Country: China

Status: Recruiting

Contact:
Last name: Wenyu SHI, MD

Phone: +86-13515203737
Email: 2305188690@qq.com

Investigator:
Last name: Wenyu SHI, MD
Email: Principal Investigator

Facility:
Name: Beijing Gobroad Hosptial

Address:
City: Beijing
Zip: 102206
Country: China

Status: Recruiting

Contact:
Last name: Kai HU, MD

Phone: +86-15010390336
Email: huk@gobroadhealthcare.com

Investigator:
Last name: Kai HU, MD
Email: Principal Investigator

Start date: April 11, 2024

Completion date: June 30, 2028

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Collaborator:
Agency: Nanjing Legend Biotech Co.
Agency class: Industry

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06295549

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