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

Not Applicable

• Conditions: Non-hodgkin's Lymphoma
• Interventions: Biological: CD19 CAR-T

• Registration Number: NCT04447547
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-29
• Primary Completion: 2022-08-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SL1904B CAR-T	CD19 CAR-T	Patients will be treated with CD19 CAR-T cells

Primary Outcome Measures

Name	Time	Method
Safety: Incidence and severity of adverse events	First month post CAR-T cells infusion	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)	3 months post CAR-T cells infusion	Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B

Secondary Outcome Measures

Name	Time	Method
Efficacy:duration of response (DOR)	24 months post CAR-T cells infusion	duration of response (DOR)
Efficacy: progression-free survival (PFS)	24 months post CAR-T cells infusion	progression-free survival (PFS) time
Cytokine release	First month post CAR-T cells infusion	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
CAR-T proliferation	3 months post CAR-T cells infusion	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

Trial Locations

Locations (2)

BeiJing Ludaopei Hospital; 🇨🇳 Beijing, Yizhuang, China

He bei Yan da Lu dao pei Hospital; 🇨🇳 Yanda, China