LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patiens

NCT04219319•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

A Phase I, Multicenter study to evaluate the safety, tolerability, and Efficacy of LCAR-T2C CAR-T cells in relapsed or refractory CD4+T Lymphocyte Tumor Patients.

Detailed Description

This is an open, dose escalation/dose extension study of LCAR-T2C CAR-T cells administrered to patients with T lymphocyte tumor. The aim of the study is to evaluate the safety, tolerability, and efficacy of LCAR-T2C CAR-T cells. The auto-CAR-T cells will be infused in single-dose.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent form (ICF)
•2. Age 18 Years to 75 Years
•3. Pathological diagnosis of refractory/relapsed CD4+ T lymphocyte tumor (one of the following):
•1. T-cell Non-Hodgkin lymphoma(T-NHL)：The best response is progressive disease(PD) or stable disease(SD) after at least 1 prior line of therapy（at least 2 complete cycle of therapy）
•2. T-cell Acute lymphoblastic leukemia(T-ALL)：The best response is not complete response(CR) after induction therapy
•4. Measurable disease is necessary at Screening
•5. Life expectancy ≥ 3 months
•6. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 -2.
•7. The screening phase clinical laboratory values meet the following criteria. Laboratory test(s) may be repeated once, to determine if the subject qualifies for study participation :
•Blood routine:
+6 more criteria

Exclusion Criteria

•1. Prior treatment with CAR-T therapy directed at any target.
•2. Any therapy that is targeted to CD4.
•3. Prior treatment with an allogeneic stem cell transplant
•4. Any malignancy besides the T lymphocyte tumor categories under study, exceptions include
•1. Any other malignancy curatively treated and disease-free for at least 2 years prior to enrollment
•2. History of non-melanoma skin cancer with sufficient treatment and currently no evidence of recurrence
•5. Those 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), and human immunodeficiency virus antibody (HIV-Ab)
•6. The following cardiac conditions:
•1. New York Heart Association (NYHA) stage III or IV congestive heart failure
•2. Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment
+25 more criteria

Locations (3)

Oncology Department，The First Affiliated Hospital of USTC west district

Hefei, Anhui, China

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, China

Hematological Department，The First Affiliated Hospital of the Air Force Medical University

Xi’an, Shanxi, China

Key Dates

Start Date

December 15, 2021

Primary Completion Date

July 20, 2022

Completion Date

July 20, 2022

Last Updated

August 16, 2022

Enrollment

ACTUAL participants

Conditions

CD4+ T Lymphocyte Tumor (T Cell Lymphoma and T Cell Leukemia)

Interventions

Efficacy of LCAR-T2C CAR-T cells

DRUG