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Clinical Study of CAR-iNKT Cells in the Treatment of Relapsed/Refractory/High-risk B-cell Tumors

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: NCT04814004
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 29, 2021
Sponsor:
Collaborators:
North Jiangsu People's Hospital
The First People's Hospital of Changzhou
Nantong University
First Affiliated Hospital of Zhejiang University
Affiliated Hospital of Jiangsu University
Huai 'an First People's Hospital
Information provided by (Responsible Party):
Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University

Study Description
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Brief Summary:
This study aims to evaluate the safety and feasibility of hCD19.IL15.CAR-iNKT cells in treating patients with relapsed/refractory/high-risk B-cell tumors.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia B-cell Lymphoma Chronic Lymphocytic Leukemia Drug: hCD19.IL15.CAR-iNKT Phase 1

Detailed Description:
CD19 CAR-T has been shown to treat a variety of refractory or recurrent B-cell tumors. Because most CAR-T cells are generated from the patient's own T cells and are individualized products, and there are individual differences between patients, the generation of customized CAR-T cells is an expensive and time-consuming process. Universal CAR- iNKT cells are an ideal product for cell therapy. In this study, we prepared universal iNKT cells expressing hCD19 CAR and IL-15 to treat refractory, relapsed, or high-risk B-cell tumors.
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: Clinical Study of CAR-iNKT Cells in the Treatment of Relapsed/Refractory/High-risk B-cell Tumors
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hCD19.IL15.CAR-iNKT cells
Dose escalation follows the accelerated titration and the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
 Drug: hCD19.IL15.CAR-iNKT
Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: Baseline up to 28 days after T cell infusion ]
    Adverse events assessed according to NCI-CTCAE v5.0 criteria


Secondary Outcome Measures :
  1. MRD negative overall response rate (MRD- ORR) [ Time Frame: 3 months ]
    Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment

  2. Overall response rate (ORR) [ Time Frame: Month 6, 12, 18 and 24 ]
    Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24

  3. Event-free survival (EFS) [ Time Frame: Month 6, 12, 18 and 24 ]
    Assessment of EFS at Month 6, 12, 18 and 24

  4. Overall survival (OS) [ Time Frame: Month 6, 12, 18 and 24 ]
    Assessment of OS at Month 6, 12, 18 and 24


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged 5-70 years;
  • The patient's ECOG score was ≤2, and the expected survival time of > was 12 weeks.
  • The patient was diagnosed with B-cell tumor by pathological and histological examination and had no effective treatment options, such as recurrence after chemotherapy or hematopoietic stem cell transplantation. Or the patient voluntarily chooses the infusion of CAR-INKT cells as the first treatment.

  • B cell tumors include the following three types:

    1. B-cell acute lymphocytic leukemia (B-ALL);
    2. Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
    3. Aggressive B-cell lymphoma (DLBCL, BL, MCL);

  • Subject:

    1. Residual lesions remain after primary treatment and are not suitable for HSCT (Auto/Allo-HSCT);
    2. relapse after complete response (CR1) and unsuitable for allogeneic/autologous HSCT;
    3. Patients with high risk factors;
    4. relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
  • having measurable or evaluable lesions;

  • The main tissues and organs of the patient function well:

    1. Liver function: ALT/AST < 3 times the upper limit of normal (ULN);
    2. Renal function: creatinine < 220μmol/L;
    3. Lung function: indoor oxygen saturation ≥95%;
    4. Heart function: left ventricular ejection fraction (LVEF) ≥40%.
  • Patients or their legal guardians voluntarily participate and sign the informed consent.

Exclusion Criteria:

  • Pregnant or lactating women, or women who plan to become pregnant within six months;
  • Infectious diseases (e.g. HIV, active hepatitis B or C infection, active tuberculosis, etc.);
  • GVHD;
  • Abnormal vital signs and failure to cooperate with the examination;
  • People with mental or mental illness who are unable to cooperate with treatment and efficacy evaluation;
  • People with high allergic constitution or severe allergic history, especially those allergic to IL-2;
  • Subjects with systemic infection or severe local infection need anti-infection therapy;
  • Complicated with dysfunction of heart, lung, brain, liver, kidney and other important organs;
  • Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥III);
  • Doctors believe that there are other reasons for not being included in treatment.
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): NCT04814004


Contacts
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Contact: Jiang Cao, Ph.D 86-516-85802007 zimu05067@163.com
Contact: Ming Shi, Ph.D 86-516-85802635 sm200@sohu.com

Locations
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China, Jiangsu
The Affiliated hospital of Xuzhou medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Jiang Cao, M.D., Ph.D.    86-516-85802007    zimu05067@163.com   
Sponsors and Collaborators
Kai Lin Xu; Jun Nian Zheng
North Jiangsu People's Hospital
The First People's Hospital of Changzhou
Nantong University
First Affiliated Hospital of Zhejiang University
Affiliated Hospital of Jiangsu University
Huai 'an First People's Hospital
Investigators
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Study Chair: Kailin Xu, Ph.d The Affiliated Hospital of Xuzhou Medical University
Study Director: Junnian Zheng, Ph.D Xuzhou Medical University
More Information
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Responsible Party: Kai Lin Xu; Jun Nian Zheng, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT04814004    
Other Study ID Numbers: XYFY2021-KL062
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell