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Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03258047
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wenbin Qian, First Affiliated Hospital of Zhejiang University

Brief Summary:

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.


Condition or disease Intervention/treatment Phase
B Cell Lymphoma Combination Product: CAR-T Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CAR-T treatment
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
Combination Product: CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: every 3 months until 20 months after the last patient's enrollment ]
    complete remission rate after treated by CAR-T therapy


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment ]
    from date of inclusion to date of progression, relapse, or death from any cause

  2. overall survival [ Time Frame: 20 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause

  3. adverse events [ Time Frame: from the date of the start of treatment to 20 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

  4. duration of the modified T cells by CAR-T in the patients [ Time Frame: from the date of re-transfusison to 20 months after last patient's enrollment ]
    time from re-transfusion to date when the modified T cells become non-detectable.



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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. Age≥18 years, male or female;
  2. Karnofsky≥60%;
  3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
  4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
  5. Patients have had more than 2 combined chemotherapy regimens;
  6. Creatinin <2.5mg/dL;ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL;
  7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
  8. Patient that could understand and is willing to sign the written consent;
  9. Fertile female patient should be willing to take contraceptive measures.
  10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria:

  1. Patients who need ≥15mg prednisone daily due to any cause;
  2. Patients with autoimmune disease and need immunosuppressor treatment;
  3. Serum creatinin>2.5 mg/dL;serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
  4. FEV1<2 L,diffusion capacity for carbon monoxide of lung (DLCO) <40%;
  5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%;
  6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
  7. Patients that have previously received gene therapy of any kind;
  8. Obvious clinical encephalopathy or novel neuron function damage;
  9. Patients with active infection;
  10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
  11. Patients who had allergic history to agents of the similar structure as CAR-T;

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): NCT03258047


Contacts
Contact: Wenbin Qian, MD,PhD (+86)13605801032 qianwenb@aliyun.com
Contact: Hui Liu, MD,PhD (+86)13819198629

Locations
China, Zhejiang
The first affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Wenbin Qian, MD. PhD.    (+86)13605801032      
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University

Responsible Party: Wenbin Qian, Doctor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03258047     History of Changes
Other Study ID Numbers: lymphoma center Q002
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the data would be available on the corresponding website of the leading research center.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin