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Tests treatment safety and results for NHL
Official title Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
ClinicalTrials.gov ID: NCT04440436
What this study is testing
What is IM19 CAR-T Cells?
IM19 CAR-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nhl.
Also referred to as Fludarabine, Cyclophosphamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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.
You likely can't join 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.
See the full eligibility criteria
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.