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

NCT ID: NCT04814004

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2024-04-01

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.

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.

Conditions

Acute Lymphoblastic Leukemia; B-cell Lymphoma; Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hCD19.IL15.CAR-iNKT

Intervention Type: DRUG

Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.

Interventions

hCD19.IL15.CAR-iNKT

Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Jiangsu People's Hospital

UNKNOWN

Sponsor Role: collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role: collaborator

Nantong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role: collaborator

Huai 'an First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Kai Lin Xu; Jun Nian Zheng

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu; Jun Nian Zheng

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kailin Xu, Ph.d

Role: STUDY_CHAIR

The Affiliated Hospital of Xuzhou Medical University

Junnian Zheng, Ph.D

Role: STUDY_DIRECTOR

Xuzhou Medical University

Locations

The Affiliated hospital of Xuzhou medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Cao, Ph.D

Role: CONTACT

zimu05067@163.com

86-516-85802007

Ming Shi, Ph.D

Role: CONTACT

sm200@sohu.com

86-516-85802635

Facility Contacts

Jiang Cao, M.D., Ph.D.

Role: primary

zimu05067@163.com

86-516-85802007

Other Identifiers

XYFY2021-KL062

Identifier Type: -

Identifier Source: org_study_id