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Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT04546906
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL

Condition or disease Intervention/treatment Phase
B-ALL Biological: CD22 CAR-T Not Applicable

Detailed Description:

The CARs consist of an anti-CD22 single-chain variable fragment(scFv), 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 CD22CAR-T in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL

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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 CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Experimental: CD22 CAR-T
Patients will be treated with CD22 CAR-T cells
Biological: CD22 CAR-T
Biological: CD22 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 CD22 CAR-T 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:

    1. B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation;
    2. Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
    3. High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy;
  2. Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood;
  3. There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence;
  4. The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2;
  5. The estimated survival time is more than 3 months;
  6. Need to sign informed consent.

Exclusion Criteria:

  1. Serious cardiac insufficiency;
  2. Has a history of severe pulmonary function damaging;
  3. Other malignant tumors;
  4. Serious infection or persistent infection and can not be effectively controlled;
  5. Merging severe autoimmune diseases or immunodeficiency disease;
  6. Patients with active hepatitis (HBV DNA or HCV RNA positive);
  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(including a history of serious mental illness, substance abuse and addiction)

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): NCT04546906


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
Heibei, 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.
Investigators
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Principal Investigator: Peihua Lu, PhD&MD Hebei Yanda Ludaopei Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04546906    
Other Study ID Numbers: CD22 CAR-T 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.:
CD22 CAR-T, B-ALL
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases