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

NCT03483688 | Completed Phase 1 DMC

• 1 other identifier: CBMG-C2017007
• Study Type: interventional
• Target: 6
• 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

B-cell Non-Hodgkin Lymphoma

Keywords

B-cell Non-Hodgkin Lymphoma; Refractory; Relapsed

Outcome Measures

Primary Outcomes (1)

• AE

  Incidence of adverse events (AEs) and serious adverse events (SAEs)

  12 weeks

Secondary Outcomes (4)

• Overall response rate (ORR)

  12 months

• Duration of remission (DOR)

  12 months

• Progression free survival (PFS)

  12 months

• Overall survival rate（OSR）

  12 months

Study Arms (1)

CD19-directed CAR-T cells

EXPERIMENTAL

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

Biological: CD19-directed CAR-T cells

Interventions

CD19-directed CAR-T cells BIOLOGICAL

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 cells (C- CAR011)

CD19-directed CAR-T cells

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,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
• DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).
• Progressive disease after the last standard chemotherapy regimens.
• Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
• Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
• Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
• Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
• Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination 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(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
• 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

• Peking Union Medical College Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (1)

• Zhang L, Zhang Y, Zhou DB. [Anti-CD19 CART (C-CAR011) Therapy for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Aug;29(4):1141-1147. doi: 10.19746/j.cnki.issn.1009-2137.2021.04.019. Chinese.

  PMID: 34362494 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daobin Zhou

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 30, 2018
• Study Start: March 6, 2018
• Primary Completion: December 10, 2019
• Study Completion: January 10, 2020
• Last Updated: March 5, 2020

Record last verified: 2018-03

Locations

CN (1)