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CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

NCT ID: NCT04626739

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-03-30

Brief Summary

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This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

Detailed Description

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Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Conditions

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Refractory Indolent Adult Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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volunteers

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma

Group Type EXPERIMENTAL

CD19 CAR-T

Intervention Type DRUG

CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma

CD22 CAR-T

Intervention Type DRUG

CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma

CD19+CD22 CAR-T

Intervention Type DRUG

CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma

Fludarabine

Intervention Type DRUG

25mg/㎡ for D-4、D-3 and D-2

Cyclophosphamide

Intervention Type DRUG

500mg/㎡ for D-3 and D-2

Interventions

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CD19 CAR-T

CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma

Intervention Type DRUG

CD22 CAR-T

CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma

Intervention Type DRUG

CD19+CD22 CAR-T

CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma

Intervention Type DRUG

Fludarabine

25mg/㎡ for D-4、D-3 and D-2

Intervention Type DRUG

Cyclophosphamide

500mg/㎡ for D-3 and D-2

Intervention Type DRUG

Other Intervention Names

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Senl_19 Senl_22 Senl_19+22 flu ctx

Eligibility Criteria

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Inclusion Criteria

1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.

To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
3. There should be at least one measurable tumor focal point;
4. Karnofsky \[2\] score 50 or more;
5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
6. The expected survival time is greater than 3 months;
7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

Exclusion Criteria

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50;
2. Has a history of severe pulmonary function damaging;
3. Merging other malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. patients with active hepatitis B or hepatitis C;
8. patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianmin luo, PhD&MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Locations

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No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianqiang Li, Phd&MD

Role: CONTACT

Phone: 86-311-82970975

Email: [email protected]

Facility Contacts

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Jianqiang Li, PhD & MD

Role: primary

Jianmin Luo, PhD & MD

Role: backup

Other Identifiers

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CAR-T for NHL

Identifier Type: -

Identifier Source: org_study_id