NHLPhase 1/2NCT04440436
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
A Phase 1/2 study testing IM19 CAR-T Cells in people with NHL, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL
- What is being tested?
- IM19 CAR-T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to 4 Jun 2035
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Yuqin Song, MD, PhD, +8618911576946
About this study
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
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.
- Conditions
- NHL
- Being tested
- IM19 CAR-T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM19 CAR-T CellsDrug
Also called Fludarabine, Cyclophosphamide
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
| Study group | Role | What they receive |
|---|---|---|
| IM19 CAR-T cells | Experimental | IM19 CAR-T cells be administrated in two dose level Receives: Drug: IM19 CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR) at 90 days
The primary endpoint was ORR 90 days after IM19 infusion
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start4 Jun 2020
- Primary completion4 Jun 2022 (estimated)
- Study completion4 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yuqin Song, MD, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440436
- Sponsor's protocol ID
- SD45
- Status last verified
- Dec 2020
- First submitted
- 18 Jun 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No