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

NCT ID: NCT04447547

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-12-30

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.

Conditions

Non-hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SL1904B CAR-T

Patients will be treated with CD19 CAR-T cells

Group Type: EXPERIMENTAL

CD19 CAR-T

Intervention Type: BIOLOGICAL

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

Interventions

CD19 CAR-T

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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;

2. The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;

3. There should be at least one measurable tumor focus according to the RECIST version 1.1;

4. ECOG Scores: 0~2;

5. The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;

6. Estimated survival time was longer than 3 months;

7. 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%；

8. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria

1. Serious cardiac insufficiency；

2. Has a history of severe pulmonary function damaging;

3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;

4. Merging the metabolic diseases (except diabetes);

5. Merging severe autoimmune diseases or immunodeficiency disease;

6. Patients with active hepatitis B or hepatitis C virus infection;

7. Patients with HIV infection or syphilis infection;

8. Has a history of serious allergies on Biological products (including antibiotics);

9. Participated in any other clinical drug trial for the last six months;

10. Being pregnant and lactating or having pregnancy within 12 months;

11. With other uncontrolled diseases and considered not suitable to participate by the researchers;

12. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Lu Daopei Hospital

OTHER

Sponsor Role: collaborator

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: collaborator

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peihua Lu, PhD&MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Lu Daopei Hospital

Locations

BeiJing Ludaopei Hospital

Beijing, Yizhuang, China

Site Status: RECRUITING

He bei Yan da Lu dao pei Hospital

Yanda, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Peihua Lu, PhD&MD

Role: CONTACT

peihua_lu@126.com

008618611636172

Jianqiang Li, PhD&MD

Role: CONTACT

limmune@gmail.com

008615511369555

Facility Contacts

Peihua Lu, PhD&MD

Role: primary

peihua_lu@126.com

008618611636172

Peihua Lu

Role: primary

Other Identifiers

1904B for NHL

Identifier Type: -

Identifier Source: org_study_id