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

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03258047
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
22.4
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Combination Product: CAR-T
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
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 :
Sep 15, 2017
Actual Primary Completion Date :
Jan 13, 2019
Anticipated Study Completion Date :
Jul 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. complete remission rate [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 [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 [20 months after the last patient's enrollment]

    from the date of inclusion to date of death, irrespective of cause

  3. adverse events [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of Zhejiang University Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wenbin Qian, Doctor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT03258047
Other Study ID Numbers:
  • lymphoma center Q002
First Posted:
Aug 22, 2017
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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

Study Results

No Results Posted as of Feb 15, 2019