A Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-NHL

NCT03299738 | Unknown Phase 1 DMC

• 1 other identifier: CBMG-C2017006
• Study Type: interventional
• Target: 10
• 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 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Conditions

Refractory or Relapsed B-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)

  Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)

  12 weeks

• Overall response rate (ORR)

  12 weeks

Secondary Outcomes (5)

• Overall response rate (ORR)

  6 months

• Overall 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
• Relapse 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 (2017 Version 1)
• Progressive disease after the last standard chemotherapy regimens per the IWG Response Criteria (1999)
• Stable disease after the last standard chemotherapy regimens (at least 4 cycles of first-line therapy or 2 cycles of later-line therapy) per the IWG Response Criteria (1999)
• Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT)
• \. Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
• At least 2 combination chemotherapy regimens (excluding single agent monoclonal antibody)
• Relapse or progressive disease within 1 year after last chemotherapy regimens
• \. Mantle cell lymphoma
• Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT
• Relapse or progressive disease within 1 year after the last chemotherapy regimens
• Relapse or progressive disease within 12 months after autologous SCT
• All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)

You may not qualify if:

• History of allergy to cellular products
• Laboratory tests: absolute neutrophil count \< 1.0 × 10\^9 /L, platelet count \< 50 × 10\^9 /L, serum albumin \< 30 g/L, serum bilirubin \> 1.5 ULN, serum creatinine \> ULN, ALT/AST \> 3 ULN
• History of CAR T cell therapy or any other genetically modified T cell therapy
• Relapse after allogeneic hematopoietic stem cell transplantation
• Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted
• Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection
• Class III or IV heart failure according to the NYHA Heart Failure Classifications
• QT interval prolongation ≥ 450 ms
• History of epilepsy or other central nervous system disorders
• Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
• History of other primary cancers, with the following exceptions
• Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
• Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer)
• Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy
• Used of systemic steroids within two weeks (using inhaled steroids is an exception)

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

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

Study Officials

• Huilai Zhang

  Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huilai Zhang

CONTACT

+86-022-23340123

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: September 28, 2017
• First Posted: October 3, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

CN (1)