Novel Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL

NCT05639179 | Unknown Phase 1

• 1 other identifier: KM-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of UCAR-T Cells injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).

Conditions

B-cell Acute Lymphoblastic Leukemia; B-ALL

Keywords

universal CAR-T(UCAR-T); CD19

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Neurotoxicity and/or CRS≥G3.

  Up to 28 days after infusion

• Incidence of Treatment Related adverse events (AEs)

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Up to 12 months after infusion

Secondary Outcomes (5)

• Persistence of CAR-T cells

  Up to 24 weeks after infusion

• Objective response rate (ORR)

  At 4,8,12 weeks after infusion

• Progression-free survival (PFS)

  Up to 24 weeks after infusion

• Overall survival (OS)

  Up to 24 weeks after infusion

• Duration of remission (DOR)

  Up to 24 weeks after infusion

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Subjects who meet the enrollment conditions will receive intravenous infusion of UCAR-T Cells after lymphodepletion.

Biological: UCAR-T Cells

Interventions

UCAR-T Cells BIOLOGICAL

UCAR-T Cellswill be administered by vein. The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set:Dose level one:1×10\^6 cells/kg;Dose level two:2×10\^6 cells/kg;Dose level three:5×10\^6 cells/kg. Each dose group requires at least three subjects. The trial will start from dose level one. The second portion includes a dosage extended cohort and will start after the finish of the"3+3"dose escalation study. Twelve subjects will get infusion of UCAR-T Cells at the best dose verified in the first portion.

Assigned Interventions

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:

• Male or female, aged 2-75 years;
• A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes \>5% in bone marrow at baseline (flow cytometry);
• CD19 expression was positive in bone marrow or peripheral blood tumor cells;
• ECOG score 0-2 points;
• Expected survival time ≥3 months;
• Adequate liver, kidney, heart and lung function;
• Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart;
• Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
• Voluntarily sign the informed consent.

You may not qualify if:

• Presence of other concurrent active malignancy;
• People with severe mental disorders;
• A history of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
• Acute GVHD of grade II-IV or extensive chronic GVHD;
• Had grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
• The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
• A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
• Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;
• Patients with severe history of allergy or allergic constitution;
• A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years;
• Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
• Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
• Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
• For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
• Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events;

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Wang Sanbin, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Sanbin, Doctor

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: November 25, 2022
• First Posted: December 6, 2022
• Study Start: December 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CN (1)