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

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ClinicalTrials.gov Identifier: NCT04447547
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-hodgkin's Lymphoma Biological: CD19 CAR-T Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: SL1904B CAR-T
Patients will be treated with CD19 CAR-T cells
Biological: CD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;




Primary Outcome Measures :
  1. Safety: Incidence and severity of adverse events [ Time Frame: 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

  2. Efficacy: Overall Remission Rate (ORR) [ Time Frame: 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 :
  1. Efficacy:duration of response (DOR) [ Time Frame: 24 months post CAR-T cells infusion ]
    duration of response (DOR)

  2. Efficacy: progression-free survival (PFS) [ Time Frame: 24 months post CAR-T cells infusion ]
    progression-free survival (PFS) time

  3. CAR-T proliferation [ Time Frame: 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

  4. Cytokine release [ Time Frame: First month post CAR-T cells infusion ]
    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447547


Contacts
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Contact: Peihua Lu, PhD&MD 008618611636172 peihua_lu@126.com
Contact: Jianqiang Li, PhD&MD 008615511369555 limmune@gmail.com

Locations
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China, Yizhuang
BeiJing Ludaopei Hospital Recruiting
Beijing, Yizhuang, China, 100000
Contact: Peihua Lu, PhD&MD    008618611636172    peihua_lu@126.com   
Principal Investigator: Peihua Lu, PhD&MD         
Sub-Investigator: Jianqiang Li, PhD&MD         
China
He bei Yan da Lu dao pei Hospital Recruiting
Yanda, China
Contact: Peihua Lu         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Investigators
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Principal Investigator: Peihua Lu, PhD&MD Beijing Lu Daopei Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04447547    
Other Study ID Numbers: 1904B for NHL
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebei Senlang Biotechnology Inc., Ltd.:
NHL,CD19
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases