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Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528421
Recruitment Status : Unknown
Verified May 2018 by Beijing Immunochina Medical Science & Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 17, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary:
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Biological: IM19 Drug: Fludarabine Drug: Cyclophosphamide Phase 1

Detailed Description:
  1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.
  2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: IM19 CAR-T cells
3*10^5/kg,1*10^6/kg,3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days
Biological: 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




Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 2 years ]
    >= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 2 years ]
    (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
  2. Patients must have evaluable disease evidence;
  3. Age ≥ 18 years old;
  4. The expected life span is more than 3 months;
  5. ECOG score 0-2 points (see Attachment 2);
  6. 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;
  7. Those who voluntarily participate in the trial and sign the informed consent.

Exclusion criteria:

  1. Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
  2. Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
  3. Use chemotherapy or radiotherapy within 3 days before the blood collection period;
  4. Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
  5. Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
  6. Those who have previously used any gene therapy products;
  7. History of epilepsy or other diseases of the central nervous system;
  8. New York Heart Association (NYHA) class III or above (see Annex 3);
  9. creatinine> 1.5 times the upper limit of normal or ALT / AST> 3 times the upper limit of normal or bilirubin> 2 times the normal upper limit;
  10. active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
  11. pregnant or lactating women;
  12. suffer from other uncontrolled diseases that the researcher considers inappropriate;
  13. Any condition that the investigator believes may increase the subject's risk or interfere with the test results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528421


Contacts
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Contact: Xin-an Lu, Dr 86-189-1157-6946 luxinan@immunochina.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Xinan Lu, Dr.         
Principal Investigator: Jun Zhu         
Sponsors and Collaborators
Beijing Immunochina Medical Science & Technology Co., Ltd.
Beijing Cancer Hospital
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Responsible Party: Beijing Immunochina Medical Science & Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03528421    
Other Study ID Numbers: YMCART201705
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Immunochina Medical Science & Technology Co., Ltd.:
CAR-T
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists