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

Primary Purpose

B Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CAR-T

About this trial

This is an interventional treatment trial for B Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age≥18 years, male or female;
Karnofsky≥60%；
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).
Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
Patients have had more than 2 combined chemotherapy regimens;
Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；
Proper venous condition for leukapheresis, no contraindication for leukapheresis;
Patient that could understand and is willing to sign the written consent;
Fertile female patient should be willing to take contraceptive measures.
Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria:

Patients who need ≥15mg prednisone daily due to any cause;
Patients with autoimmune disease and need immunosuppressor treatment;
Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
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%；
Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
Patients that have previously received gene therapy of any kind;
Obvious clinical encephalopathy or novel neuron function damage;
Patients with active infection;
Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
Patients who had allergic history to agents of the similar structure as CAR-T;

Sites / Locations

The first affiliated hospital of Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T treatment

Arm Description

In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

Outcomes

Primary Outcome Measures

complete remission rate

complete remission rate after treated by CAR-T therapy

Secondary Outcome Measures

progression free survival

from date of inclusion to date of progression, relapse, or death from any cause

overall survival

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

adverse events

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

duration of the modified T cells by CAR-T in the patients

time from re-transfusion to date when the modified T cells become non-detectable.

Full Information

NCT ID

NCT03258047

First Posted

August 20, 2017

Last Updated

February 13, 2019

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03258047

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2017 (Actual)

Primary Completion Date

January 13, 2019 (Actual)

Study Completion Date

July 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAR-T treatment

Arm Type

Experimental

Arm Description

In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

Intervention Type

Combination Product

Intervention Name(s)

CAR-T

Intervention Description

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 Measure Information:

Title

complete remission rate

Description

complete remission rate after treated by CAR-T therapy

Time Frame

every 3 months until 20 months after the last patient's enrollment

Secondary Outcome Measure Information:

Title

progression free survival

Description

from date of inclusion to date of progression, relapse, or death from any cause

Time Frame

from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment

Title

overall survival

Description

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

Time Frame

20 months after the last patient's enrollment

Title

adverse events

Description

Time Frame

from the date of the start of treatment to 20 months after last patient's enrollment

Title

duration of the modified T cells by CAR-T in the patients

Description

time from re-transfusion to date when the modified T cells become non-detectable.

Time Frame

from the date of re-transfusison to 20 months after last patient's enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥18 years, male or female; Karnofsky≥60%； 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). Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons. Patients have had more than 2 combined chemotherapy regimens; Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL； Proper venous condition for leukapheresis, no contraindication for leukapheresis; Patient that could understand and is willing to sign the written consent; Fertile female patient should be willing to take contraceptive measures. Patient that is willing to follow up till at least 2 months after T cell re-transfusion. Exclusion Criteria: Patients who need ≥15mg prednisone daily due to any cause; Patients with autoimmune disease and need immunosuppressor treatment; Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl; FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%； 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%； Patients with HIV infection, active Hepatitis B or Hepatitis C infection; Patients that have previously received gene therapy of any kind; Obvious clinical encephalopathy or novel neuron function damage; Patients with active infection; Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment; Patients who had allergic history to agents of the similar structure as CAR-T;

Facility Information:

Facility Name

The first affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All the data would be available on the corresponding website of the leading research center.

Learn more about this trial

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

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