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Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

Primary Purpose

Non-hodgkin's Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CD19 CAR-T

About this trial

This is an interventional treatment trial for Non-hodgkin's Lymphoma focused on measuring NHL，CD19

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
There should be at least one measurable tumor focus according to the RECIST version 1.1;
ECOG Scores: 0~2;
The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
Estimated survival time was longer than 3 months;
main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation >92%；
Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

Serious cardiac insufficiency；
Has a history of severe pulmonary function damaging;
With other tumors which is/are in advanced malignant and has/have systemic metastasis;
Merging the metabolic diseases (except diabetes);
Merging severe autoimmune diseases or immunodeficiency disease;
Patients with active hepatitis B or hepatitis C virus infection;
Patients with HIV infection or syphilis infection;
Has a history of serious allergies on Biological products (including antibiotics);
Participated in any other clinical drug trial for the last six months;
Being pregnant and lactating or having pregnancy within 12 months;
With other uncontrolled diseases and considered not suitable to participate by the researchers;
Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Sites / Locations

BeiJing Ludaopei HospitalRecruiting
He bei Yan da Lu dao pei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SL1904B CAR-T

Arm Description

Patients will be treated with CD19 CAR-T cells

Outcomes

Primary Outcome Measures

Safety: Incidence and severity of adverse events

To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Efficacy: Overall Remission Rate (ORR)

Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B

Secondary Outcome Measures

Efficacy:duration of response (DOR)

duration of response (DOR)

Efficacy: progression-free survival (PFS)

progression-free survival (PFS) time

CAR-T proliferation

the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method

Cytokine release

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Full Information

NCT ID

NCT04447547

First Posted

June 22, 2020

Last Updated

September 25, 2020

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04447547

Brief Title

Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

Official Title

Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2020 (Actual)

Primary Completion Date

August 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma The Secondary research objectives: To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.

6. Conditions and Keywords

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

Non-hodgkin's Lymphoma

Keywords

NHL，CD19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SL1904B CAR-T

Arm Type

Experimental

Arm Description

Patients will be treated with CD19 CAR-T cells

Intervention Type

Biological

Intervention Name(s)

CD19 CAR-T

Intervention Description

Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Primary Outcome Measure Information:

Title

Safety: Incidence and severity of adverse events

Description

To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Time Frame

First month post CAR-T cells infusion

Title

Efficacy: Overall Remission Rate (ORR)

Description

Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B

Time Frame

3 months post CAR-T cells infusion

Secondary Outcome Measure Information:

Title

Efficacy:duration of response (DOR)

Description

duration of response (DOR)

Time Frame

24 months post CAR-T cells infusion

Title

Efficacy: progression-free survival (PFS)

Description

progression-free survival (PFS) time

Time Frame

24 months post CAR-T cells infusion

Title

CAR-T proliferation

Description

the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method

Time Frame

3 months post CAR-T cells infusion

Title

Cytokine release

Description

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Time Frame

First month post CAR-T cells infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma; There should be at least one measurable tumor focus according to the RECIST version 1.1; ECOG Scores: 0~2; The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry; Estimated survival time was longer than 3 months; main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation >92%； Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. Exclusion Criteria: Serious cardiac insufficiency； Has a history of severe pulmonary function damaging; With other tumors which is/are in advanced malignant and has/have systemic metastasis; Merging the metabolic diseases (except diabetes); Merging severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C virus infection; Patients with HIV infection or syphilis infection; Has a history of serious allergies on Biological products (including antibiotics); Participated in any other clinical drug trial for the last six months; Being pregnant and lactating or having pregnancy within 12 months; With other uncontrolled diseases and considered not suitable to participate by the researchers; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Central Contact Person:

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

Peihua Lu, PhD&MD

Phone

008618611636172

peihua_lu@126.com

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

Jianqiang Li, PhD&MD

Phone

008615511369555

limmune@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

Organizational Affiliation

Beijing Lu Daopei Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

BeiJing Ludaopei Hospital

City

Beijing

State/Province

Yizhuang

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

Phone

008618611636172

peihua_lu@126.com

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

First Name & Middle Initial & Last Name & Degree

Jianqiang Li, PhD&MD

Facility Name

He bei Yan da Lu dao pei Hospital

City

Yanda

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peihua Lu

12. IPD Sharing Statement

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Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

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