Study of Safety and Efficacy of C-CAR011 in B-NHL Patients

NCT03154775 | Unknown Phase 1 DMC

• 1 other identifier: CBMG-C2017003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Conditions

Refractory or Relapsed Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Safety(Incidence of adverse events)

  Incidence of adverse events (AEs)

  12 weeks

• Objective response rate (ORR)

  12 weeks

Secondary Outcomes (4)

• Objective response rate (ORR)

  12 months

• Duration of remission(DOR)

  12 months

• Progression free survival(PFS)

  12 months

• Overall survival(OS)

  12 months

Study Arms (1)

C-CAR011

EXPERIMENTAL

Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene

Biological: C-CAR011

Interventions

C-CAR011 BIOLOGICAL

Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10\^6 anti-CD19 CAR+ T cells/kg

Also known as: Anti-CD19 Chimeric Antigen Receptor T cell

C-CAR011

Eligibility Criteria

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

You may qualify if:

• Volunteered to participate in this study and signed informed consent
• Age 18-70 years old, male or female
• Relapsed or refractory B cell non-Hodgkin's lymphoma
• Histologically diagnosed as DLBCL(including PMBCL) or follicular lymphoma(grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (1st edition 2017)
• Progressive disease after the last standard chemotherapy regimens
• Stable disease after the last standard chemotherapy regimens
• Relapsed within 12 months after prior autologous SCT
• Follicular lymphoma(stage Ⅲ-Ⅳ)(grade Ⅰ-Ⅲa)
• At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
• Less than 1 year between last chemotherapy and progression
• Mantle cell lymphoma
• Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
• Disease relapsed or progressed after most recent therapy
• Relapsed within 12 months after prior autologous SCT
• All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)

You may not qualify if:

• Prior treatment with CAR T therapy or any other genetically modified T cell therapy
• Relapse after allogeneic hematopoietic stem cell transplantation
• Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
• Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people
• Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
• QT interval prolongation≥450 ms
• A history of epilepsy or other central nervous system disorders
• No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
• The patient had a history of other primary cancers, with the following exceptions
• Excisional non-melanoma such as cutaneous basal cell carcinoma
• Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer
• Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
• Used of systemic steroids within two weeks (using inhaled steroids is an exception)
• Women who are pregnant or lactating or have breeding intent in 6 months
• Participated in any other clinical trial within three months

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (1)

Department of Hematology,Shanghai Tongji Hospital, Tongji University School of Medicin

Shanghai, 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

Central Study Contacts

Aibin Liang, MD,Ph.D.

CONTACT

0086-021-66111019; lab7182@tongji.edu.cn

Ping Li, MD,Ph.D.

CONTACT

0086-021-66111015; lilyforever76@126.com

Study Design

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

Study Record Dates

• First Submitted: May 13, 2017
• First Posted: May 16, 2017
• Study Start: May 3, 2017
• Primary Completion: April 30, 2018
• Study Completion: December 31, 2018
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

CN (1)