Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
NCT ID: NCT04440436
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2020-06-04
2035-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IM19 CAR-T cells
IM19 CAR-T cells be administrated in two dose level
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuqin Song, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yuqin Song, MD, PhD
Role: primary
Other Identifiers
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SD45
Identifier Type: -
Identifier Source: org_study_id