The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma

NCT04169932 | Unknown Early Phase 1

• 1 other identifier: 20191023V1.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.

Conditions

Relapsed and Refractory B Cell Lymphoma; Non-Hodgkin Lymphoma

Keywords

CD20 CAR T Cells; Safety, tolerance and efficacy

Outcome Measures

Primary Outcomes (4)

• The Adverse events (AEs)

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  4 weeks

• Expression of CD20 CART cells

  Expression of CD20 CART cells detected by flow cytometry in blood and bone marrow

  2 years

• Detection of CD20 CART cells

  Detection of CD20 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).

  2 years

• Graft Activity Endpoint Detection

  The vector copy number (VCN) of the exogenous CAR vector in the blood and bone marrow.

  2 years

Secondary Outcomes (6)

• Overall remission rate (ORR)

  2 years

• Complete Remission (CR)

  2 years

• Partial Remission (PR)

  2 years

• To evaluate the duration of remission (DOR)

  2 years

• To evaluate the Progression-free survival (PFS)

  2 years

Study Arms (1)

CD20 CAR-T

EXPERIMENTAL

Biological: CD20 CAR-T

Interventions

CD20 CAR-T BIOLOGICAL

The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg).

CD20 CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory as defined by not achieving a PR after a second-line drug therapy such as CD20 monoclonal antibodies, or achieving a PR but the disease has progressed, or chieving a CR but the disease has relapsed.
• Relapse after autologous stem cell transplantation (SCT) within 1 year.
• \. Adult subjects between 18 and 70 years of age, inclusive.
• \. Life expectancy \> 3 months.
• \. ECOG score between 0 and 1.
• \. Liver, Renal, Heart and Lungs function defined as:
• Creatininec≤1.5 ULN;
• ALT/AST ≤2.5 ULN;
• Total Bilirubin≤1.5×ULN;
• Pulse oxygenation≥92%;
• Left Ventricular Shortening Fraction (LVSF)≥50%;
• Echocardiogram (ECHO) shows no obvious pericardial effusion.
• \. According to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma, the lesions must meet the minimum size requirement of being \>15 mm in longest diameter (LDi).
• \. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.

You may not qualify if:

• \. Pregnant or lactating women, or women with pregnancy plans within 6 months.
• \. HBsAg or the titer of HBV was not in the range of normal reference value; positive for presence of HCV antibody or HCV RNA in peripheral blood; positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2).
• \. Severe heart disease: include but not limited to Unstable angina pectoris, myocardial infarction (within 6 months before screening), Congestive heart failure (New York Heart Association \[NYHA\] Classification ≥ III).
• \. Previously received other CART therapy or transgenic cell therapy.
• \. The subjects participated in clinical trials within 6 months before screening.
• \. Subjects who were receiving systemic steroid therapy and determined by the researchers to require long-term use of systemic steroid therapy except for inhalation or local use before screening.
• \. Subjects who had more than 2 years of autoimmune disease history (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that caused organ damage or subjects who needed to take systemic immunosuppressants;
• \. Any unstable systemic disease, including but not limited to, liver, kidney or metabolic diseases requiring drug treatment.
• \. Autologous transplantation or allotransplantation was performed within 6 months after admission.
• \. Evidence or history of central nervous system involvement in lymphoma.
• \. Subjects with active bleeding caused by the involvement of the original lesion in the digestive tract.
• \. Subjects with active infectious diseases who received systematic antibiotic treatment within 2 weeks of admission.
• \. Other subjects judged by the researchers to be unsuitable for admission to the study.

Sponsors & Collaborators

• Shanghai Longyao Biotechnology Inc., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi Yao, ph.D

  Shanghai Longyao Bio-Tech Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Tengfeng Ni, Master

CONTACT

+86 021- 66289710; nitengfeng@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 20, 2019
• Study Start: November 22, 2019
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CN (1)