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

March 24, 2021 updated by: Kai Lin Xu; Jun Nian Zheng
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ming Shi, Ph.D
  • Phone Number: 86-516-85802635
  • Email: sm200@sohu.com

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital Of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity
Time Frame: Baseline up to 28 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Baseline up to 28 days after T cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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
Month 6, 12, 18 and 24
Event-free survival (EFS)
Time Frame: Month 6, 12, 18 and 24
Assessment of EFS at Month 6, 12, 18 and 24
Month 6, 12, 18 and 24
Overall survival (OS)
Time Frame: Month 6, 12, 18 and 24
Assessment of OS at Month 6, 12, 18 and 24
Month 6, 12, 18 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Lin Xu; Jun Nian Zheng

Collaborators

First Affiliated Hospital of Zhejiang University
Nantong University
Affiliated Hospital of Jiangsu University
The First People's Hospital of Changzhou
North Jiangsu People's Hospital
Huai 'an First People's Hospital

Investigators

  • Study Chair: Kailin Xu, Ph.d, The Affiliated Hospital Of Xuzhou Medical University
  • Study Director: Junnian Zheng, Ph.D, Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2021-KL062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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