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

NCT04814004 | Unknown Phase 1 DMC

• 1 other identifier: XYFY2021-KL062
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after T cell infusion

Secondary Outcomes (4)

• MRD negative overall response rate (MRD- ORR)

  3 months

• Overall response rate (ORR)

  Month 6, 12, 18 and 24

• Event-free survival (EFS)

  Month 6, 12, 18 and 24

• Overall survival (OS)

  Month 6, 12, 18 and 24

Study Arms (1)

hCD19.IL15.CAR-iNKT cells

EXPERIMENTAL

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

Interventions

hCD19.IL15.CAR-iNKT DRUG

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

hCD19.IL15.CAR-iNKT cells

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• B-cell acute lymphocytic leukemia (B-ALL);
• Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
• Aggressive B-cell lymphoma (DLBCL, BL, MCL);
• Subject:
• Residual lesions remain after primary treatment and are not suitable for HSCT (Auto/Allo-HSCT);
• relapse after complete response (CR1) and unsuitable for allogeneic/autologous HSCT;
• Patients with high risk factors;
• 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:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kai Lin Xu; Jun Nian Zheng: lead
• North Jiangsu People's Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator
• Nantong University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Affiliated Hospital of Jiangsu University: collaborator
• Huai 'an First People's Hospital: collaborator

Study Sites (1)

The Affiliated hospital of Xuzhou medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kailin Xu, Ph.d

  The Affiliated Hospital of Xuzhou Medical University

  STUDY CHAIR

• Junnian Zheng, Ph.D

  Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Jiang Cao, Ph.D

CONTACT

86-516-85802007; zimu05067@163.com

Ming Shi, Ph.D

CONTACT

86-516-85802635; sm200@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 19, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)