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

NCT04440436 | Recruiting Phase 1 DMC

• 1 other identifier: SD45
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NHL

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR) at 90 days

  The primary endpoint was ORR 90 days after IM19 infusion

  90 days

Study Arms (1)

IM19 CAR-T cells

EXPERIMENTAL

IM19 CAR-T cells be administrated in two dose level

Drug: IM19 CAR-T Cells

Interventions

IM19 CAR-T Cells DRUG

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

Also known as: Fludarabine, Cyclophosphamide

IM19 CAR-T cells

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead
• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

fludarabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Yuqin Song, MD, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058; wufei@immunochina.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: June 18, 2020
• First Posted: June 19, 2020
• Study Start: June 4, 2020
• Primary Completion: June 4, 2022
• Study Completion (Estimated): June 4, 2035
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)