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

Sponsor
Kai Lin Xu; Jun Nian Zheng (Other)
Overall Status
Recruiting
CT.gov ID
NCT04814004
Collaborator
North Jiangsu People's Hospital (Other), The First People's Hospital of Changzhou (Other), Nantong University (Other), First Affiliated Hospital of Zhejiang University (Other), Affiliated Hospital of Jiangsu University (Other), Huai 'an First People's Hospital (Other)
20
Enrollment
1
Location
1
Arm
36.4
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Mar 19, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Dose-limiting toxicity [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) [3 months]

    Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment

  2. Overall response rate (ORR) [Month 6, 12, 18 and 24]

    Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24

  3. Event-free survival (EFS) [Month 6, 12, 18 and 24]

    Assessment of EFS at Month 6, 12, 18 and 24

  4. Overall survival (OS) [Month 6, 12, 18 and 24]

    Assessment of OS at Month 6, 12, 18 and 24

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The Affiliated hospital of Xuzhou medical University Xuzhou Jiangsu China 221000

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Mar 24, 2021
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Mar 29, 2021