A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies

NCT ID: NCT05654038

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2024-12-31

Brief Summary

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 universal CAR-NK(UCAR-NK) cells therapy combined with HSCT for B cell hematologic malignancies.

Detailed Description

Who can participate? Patients who were diagnosed with B cell hematologic malignancies and tumor cells expressing CD19.

How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-CD19 UCAR-NK cells, which belong to chimeric antigen receptor modified NK cells. The administration time is 1-7 days after hematopoietic stem cell infusion. Patients were then evaluated for long-term efficacy and safety until 2 years after UCAR-NK cells infusion.

What are the possible benefits and risks of participating? Benefits: The Dual effect of anti-tumor and anti-infection of NK cells may be used to promote the engraftment of hematopoietic stem cell and better disease control.

Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly other unknown adverse reactions.

Conditions

B-Cell Lymphoblastic Leukemia/Lymphoma

Keywords

universal CAR-NK(UCAR-NK); Hematopoietic Stem Cell Transplantation(HSCT)

Study Design

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

Study Groups

Target CD19 UCAR-NK cells

Subjects who meet the enrollment conditions will receive intravenous infusion of anti-CD19 UCAR-NK Cells within 1 week after hematopoietic stem cell infusion.

Group Type: EXPERIMENTAL

Anti-CD19 UCAR-NK cells

Intervention Type: BIOLOGICAL

The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of UCAR-NK cells:Dose level one: 5-10×10\^6/kg; Dose level two:1-2×10\^7/kg; Dose level three:2-5×10\^7/kg.

Interventions

Anti-CD19 UCAR-NK cells

The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of UCAR-NK cells:Dose level one: 5-10×10\^6/kg; Dose level two:1-2×10\^7/kg; Dose level three:2-5×10\^7/kg.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients with indications for hematopoietic stem cell transplantation;

2. Age ≤75 years old;

3. Confirmed B-cell tumor and tumor cells expressing CD19；

4. Expected survival time >12 weeks;

5. Eastern cooperative oncology group (ECOG) score is 0-2;

6. Adequate liver , kidney and cardiopulmonary function;

7. Willingness to complete the informed consent process and to comply with study procedures and visit schedule.

Exclusion Criteria

1. Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;

2. At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;

3. Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher graft versus host disease(GVHD) requiring immunosuppressive therapy occurred within 2 weeks before screening;

4. Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;

5. Have received live attenuated vaccine within 6 weeks before rinsing;

6. Had a cerebrovascular accident or seizure within 6 months before screening;

7. History of deep venous thrombosis or pulmonary embolism within 6 months before screening;

8. A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;

9. Previous history of Alzheimer's disease;

10. Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening;

11. There are uncontrollable infections;

12. Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion;

13. Conditions that other researchers deemed inappropriate for participating in the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Locations

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sanbin Wang, MD

Role: CONTACT

Phone: 13187424131

Email: Sanbin1011@163.com

Facility Contacts

Chen Li

Role: primary

Other Identifiers

KM-011

Identifier Type: -

Identifier Source: org_study_id