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The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

Primary Purpose

Relapsed or Refractory B-cell Lymphomas

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CD20 CAR-T cells

About this trial

This is an interventional treatment trial for Relapsed or Refractory B-cell Lymphomas focused on measuring B-cell leukemia

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation.

2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.

5. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.

9.ECOG评分≤2. 10. Patients need to sign informed consent.

Exclusion Criteria:

The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
The patient is an active hepatitis B or hepatitis C infection.
The patient received genetic product treatment within six months.
The patient participated in a clinical trial within six months.
The patient has a severe autoimmune disease.
The doctor thinks that there are other reasons that can't be accepted.

Sites / Locations

The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD20 CAR-T cells

Arm Description

Experimental: CD20 CAR-T cells

Outcomes

Primary Outcome Measures

Study related adverse events [ Time Frame: 4 weeks ]

Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.

Secondary Outcome Measures

Graft Activity Endpoint Detection

The PCR method was used to detect the copy number of the exogenous CAR vector in the blood until the end of the test was negative for both tests.

Full Information

NCT ID

NCT03576807

First Posted

June 21, 2018

Last Updated

June 21, 2018

Sponsor

Xin Wang

1. Study Identification

Unique Protocol Identification Number

NCT03576807

Brief Title

The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

Official Title

The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 4, 2018 (Actual)

Primary Completion Date

April 3, 2019 (Anticipated)

Study Completion Date

April 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xin Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.

Detailed Description

The main purpose: To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas. The Secondary purpose: The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma. The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents. Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci. Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain. Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).

6. Conditions and Keywords

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

Relapsed or Refractory B-cell Lymphomas

Keywords

B-cell leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD20 CAR-T cells

Arm Type

Experimental

Arm Description

Experimental: CD20 CAR-T cells

Intervention Type

Drug

Intervention Name(s)

CD20 CAR-T cells

Intervention Description

A total of 1 - 20×10^6 CD20 CAR-T cells/kg will be administered by IV infusions.

Primary Outcome Measure Information:

Title

Study related adverse events [ Time Frame: 4 weeks ]

Description

Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Graft Activity Endpoint Detection

Description

The PCR method was used to detect the copy number of the exogenous CAR vector in the blood until the end of the test was negative for both tests.

Time Frame

24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1．Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation. 2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%. 5. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications. 9.ECOG评分≤2. 10. Patients need to sign informed consent. Exclusion Criteria: The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months; Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.); The patient is an active hepatitis B or hepatitis C infection. The patient received genetic product treatment within six months. The patient participated in a clinical trial within six months. The patient has a severe autoimmune disease. The doctor thinks that there are other reasons that can't be accepted.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JIANG CAO, DOCTOR

Phone

+86 1385243263

zimu05067@163.com

Facility Information:

Facility Name

The Affiliated Hospital of Xuzhou Medical University

City

Xuzhou

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kailin K Xu, DOCTOR

Phone

+86 0516 85802398

lihmd@163.com

First Name & Middle Initial & Last Name & Degree

Jiang Cao, DOCTOR

Phone

+86 13852432263

zimu05067@163.com

First Name & Middle Initial & Last Name & Degree

Kailin K Xu, DOCTOR

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

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