CClinicalTrials.gg
RecruitingNCT04440436Updated Dec 8, 2020

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

A Phase 1/2 interventional study of IM19 CAR-T Cells in NHL, sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2022, 4 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2020; still recruiting 6 years 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • NHL
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 52 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd. is the lead sponsor of 26 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    IM19 CAR-T cells

    IM19 CAR-T cells be administrated in two dose level

    Drug: IM19 CAR-T Cells

Interventions

  • DrugIM19 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

    Also known as: Fludarabine, Cyclophosphamide

06

What researchers measure

Primary outcomes

  1. Objective Response Rate(ORR) at 90 days

    The primary endpoint was ORR 90 days after IM19 infusion

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing, China
    • Yuqin Song, MD, PhD · Contact · +8618911576946
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04440436
Lead sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 19, 2020
Start date
Jun 4, 2020
Primary completion
Jun 4, 2022 (estimated)
Completion
Jun 4, 2035 (estimated)
Last update
Dec 8, 2020

Study contacts

Fei Wu, MD
Contact
wufei@immunochina.com
+8615801390058
Yuqin Song, MD, PhD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion