CD19-targeting CAR T Cells for B Cell Lymphoma

NCT02547948 | Withdrawn Phase 1 DMC

• 1 other identifier: CD19-targeting CAR T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Conditions

B Cell Lymphoma

Keywords

CD19; CAR T Cells; Lymphoma

Outcome Measures

Primary Outcomes (1)

• CAR T cell persistence

  Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood

  up to 24 months

Secondary Outcomes (1)

• Tumor load

  up to 24 months

Other Outcomes (1)

• B cell number and immunoglobulins

  up to 24 months

Study Arms (2)

CAR T cells

EXPERIMENTAL

In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.

Biological: CD19-targeting CAR T Cells infusion

No Intervention

NO INTERVENTION

Interventions

CD19-targeting CAR T Cells infusion BIOLOGICAL

CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma

CAR T cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory CD19+ B-cell lymphoma.
• Measurable disease.
• Performance status ECOG 0-2.
• Age:18-80.
• Fertile females/males must consent to use contraceptives during participation of the trial.
• Signed informed consent

You may not qualify if:

• Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
• Patients with primary CNS lymphoma.
• Known human immunodeficiency virus (HIV) infection.
• Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
• Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
• Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
• Patients that do not consent to that tissue and blood samples are stored in a biobank.
• Pregnancy.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Lizhi Niu, PhD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: August 15, 2016
• Study Completion: August 15, 2016
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

CN (1)