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Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546893
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
Hebei Yanda Ludaopei Hospital
Beijing Lu Daopei Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Study Description
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Brief Summary:
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

Condition or disease Intervention/treatment Phase
B-ALL 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 1904B in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

Study Design
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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: Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1904B CAR-T
Patients will be treated with CD19 CAR-T cells
 Biological: CD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;


Outcome Measures
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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: Remission Rate [ Time Frame: 3 months post CAR-T cells infusion ]
    Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)


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


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign the informed consent 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. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
  3. ECOG Scores: 0~2
  4. CD19 positivewere detected by immunohistochemistry or flow cytometry;
  5. Estimated survival time>3 months;
  6. 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. Severe or persistent infection that cannot be effectively controlled；
  5. Merging severe autoimmune diseases or immunodeficiency disease;
  6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
  7. Patients with HIV infection or syphilis infection;
  8. Has a history of serious allergies on Biological products (including antibiotics);
  9. Being pregnant and lactating or having pregnancy within 12 months;
  10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Contacts and Locations
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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): NCT04546893


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, Sanhe
Hebei yanda Ludaopei Hospital Recruiting
Hebei, Sanhe, China, 065200
Contact: Peihua Lu, PhD&MD    008618611636172    peihua_lu@126.com   
Principal Investigator: Peihua Lu, PhD&MD         
Sub-Investigator: Jianqiang Li, PhD&MD         
China, Yizhuang
BeiJing Ludaopei Hospital Recruiting
Beijing, Yizhuang, China, 100000
Contact: Peihua Lu, PhD&MD    008618611636172    peihua_lu@126.com   
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Yanda Ludaopei Hospital
Beijing Lu Daopei Hospital
Investigators
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Principal Investigator: Peihua Lu, PhD&MD Hebei Yanda Ludaopei Hospital
More Information
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04546893    
Other Study ID Numbers: 1904B for B-ALL
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 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.:
B-ALL, CD19 CAR-T
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms