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Recruiting NCT04440436

Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

Phase I / Phase II Interventional NHL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IM19 CAR-T Cells.
Who it may be relevant to
Registry conditions: NHL. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

Overview

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Detailed description

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Interventions

  • Drug IM19 CAR-T Cells
    IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Primary outcome measures

  • Objective Response Rate(ORR) at 90 days [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
  • CD20 positive patients undergo corresponding targeted therapy.
  • Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
  • ≥ 18 years old.
  • The expected survival period is more than 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up
  • Participate voluntarily in this experiment and sign the informed consent.

Exclusion criteria

  • The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
  • Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
  • Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
  • Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
  • Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
  • Subject has used any gene therapy products before.
  • Subject with a history of epilepsy or other central nervous system diseases.
  • Active Hepatitis B Virus or Hepatitis C Virus infections
  • The subject with other tumors in the past 5 years.
  • Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT04440436 · SD45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗