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

NCT05654038 | Unknown Phase 1

• 1 other identifier: KM-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

B-Cell Lymphoblastic Leukemia/Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.

  Up to 12 months after infusion

Secondary Outcomes (7)

• Granulocyte implantation time

  Up to 1 month after infusion

• Platelet implantation time

  Up to 1 month after infusion

• Red blood cell implantation time

  Up to 1 month after infusion

• Duration of remission (DOR)

  Up to 24 weeks after infusion

• Disease control rate (DCR)

  Up to 24 weeks after infusion

Study Arms (1)

Target CD19 UCAR-NK cells

EXPERIMENTAL

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

Biological: Anti-CD19 UCAR-NK cells

Interventions

Anti-CD19 UCAR-NK cells 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.

Target CD19 UCAR-NK cells

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indications for hematopoietic stem cell transplantation;
• Age ≤75 years old;
• Confirmed B-cell tumor and tumor cells expressing CD19；
• Expected survival time \>12 weeks;
• Eastern cooperative oncology group (ECOG) score is 0-2;
• Adequate liver , kidney and cardiopulmonary function;
• Willingness to complete the informed consent process and to comply with study procedures and visit schedule.

You may not qualify if:

• Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;
• At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;
• 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;
• Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
• Have received live attenuated vaccine within 6 weeks before rinsing;
• Had a cerebrovascular accident or seizure within 6 months before screening;
• History of deep venous thrombosis or pulmonary embolism within 6 months before screening;
• A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;
• Previous history of Alzheimer's disease;
• 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;
• There are uncontrollable infections;
• 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;
• Conditions that other researchers deemed inappropriate for participating in the study.

Sponsors & Collaborators

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

Study Sites (1)

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

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sanbin Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, MD

CONTACT

13187424131; Sanbin1011@163.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

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: December 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

CN (1)