INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia

NCT06209671 | Unknown Phase 1

• 1 other identifier: INS1901
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia

Conditions

Leukemia, B-cell

Keywords

INS19 CAR-T; Acute B-lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Related adverse events (AEs)

  Incidence of adverse events associated with CAR-T treatment, abnormal clinically significant laboratory findings, including dose-limiting toxicity (DLT) and maximum-tolerated Dose (MTD).

  Up to 28 days after CAR-T cell infusion

• Persistence of CAR-T cells

  cell counts and cell percentage in peripheral blood and bone marrow

  Up to 24 weeks after CAR-T cell infusion

Secondary Outcomes (8)

• Objective response rate (ORR)

  At 28 days, 3 months and 6 months after CAR-T cell infusion

• Relapse free survival (RFS)

  At 28 days, 3 months and 6 months after CAR-T cell infusion

• Relapse free survival (RFS)

  Up to 24 months after CAR-T cell infusion

• Duration of response (DOR)

  Up to 24 months after CAR-T cell infusion

• Overall survival (OS)

  Up to 24 months after CAR-T cell infusion

Study Arms (1)

INS19 CAR-T Cells

EXPERIMENTAL

After preconditioning with chemotherapy, INS19 CAR-T Cells will be evaluated

Biological: INS19 CAR-T Cells

Interventions

INS19 CAR-T Cells BIOLOGICAL

INS19 CAR-T Cells, 1-2×10\^7 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline.

INS19 CAR-T Cells

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with relapsed or refractory acute B-lymphoblastic leukemia who meet one of the following criteria and are diagnosed as CD19 positive by flow cytometry or histology, with the following provisions for the patient's prior treatment:
• or more bone marrow relapses;
• Chemoresistance: relapse after chemotherapy and failure to achieve complete remission (MRD \>1%) with at least 1 additional course of chemotherapy;
• Relapse after autologous or allogeneic hematopoietic stem cell transplantation: time from transplantation to reinfusion is at least greater than 6 months;
• Primary refractory: complete remission not achieved after two courses of standard chemotherapy (MRD \>1%); 2. Philadelphia chromosome-positive (Ph+) patients are required to meet the following criteria: they should have received at least one relapse or refractory treatment with a tyrosine kinase inhibitor (TKI) agent ± chemotherapy or be intolerant of relapse or refractory to treatment with a TKI analog ± chemotherapy; Ph+ acute lymphoblastic leukemia (ALL) known to be accompanied by a T315I mutation, in the absence of an effective treatment with a TKI analog, is not require patients to be treated with TKI analogs ± chemotherapy; 3. Patients must have evaluable evidence of disease (bone marrow morphology suggestive of ≥5% primitive naive cells or bone marrow MRD \>1%); 4. Age 3-70, including boundary values; 5. Expected survival of 3 months or more; 6. Eastern Cooperative Oncology Group (ECOG) score of 0-1 for patients aged 16 years and older (refer to Attachment 1); Lansky score of \>50 for patients under 16 years of age (refer to Attachment 2); 7. Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception for the duration of the trial until the last follow-up visit; male subjects whose partners are of childbearing potential agree to use effective contraception for the duration of the trial until the last follow-up visit; 8. Blood cell analysis meet the requirement 9. Adequate organ function 10. Toxicity due to prior therapy has stabilized or recovered to ≤ grade 1 or is not considered clinically significant by the investigator; 11. Volunteer to participate in this trial and sign on the informed consent

You may not qualify if:

• Isolated extramedullary disease relapse;
• Leukemia patients with symptoms of significant central nervous system invasion and requiring targeted therapy;
• Prior treatment with a gene product;
• Plasmapheresis with symptoms of compression (e.g., pleural effusion, abdominal effusion);
• Patients with cardiac involvement and gastrointestinal involvement;
• Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiac disease within 6 months prior to the start of screening; patients with NYHA scores greater than Class I (or is it Class II);
• Patients with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to the start of screening; or requiring long-term antiplatelet therapy; or undergoing anticoagulation therapy;
• Allergy to the study drug and related ingredients (e.g., albumin);
• Those with Graft-versus-host disease (GVHD) requiring immunosuppression; or GVHD ≥ grade 2 or on anti-GVHD therapy; use of any medication for the treatment of GVHD within 4 weeks prior to enrollment; or autoimmune disease;
• Provisions for prior medication:
• Systemic therapy (including chemotherapy, TKI inhibitors, and belintuzumab) 1 week or 5 half-lives prior to the cell collection period; clofarabine or cladribine within 3 months prior to enrollment, or pembrolizumab within 3 weeks prior to enrollment;
• Those who have combined systemic steroid medications within 5 days prior to the cell collection period (except those who have recently or are currently using topical or inhaled steroids);
• Those who have used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to the cell collection period;
• Patients who have participated in another clinical study within 1 month prior to screening; or who are scheduled to participate in a clinical trial of another drug during this study; however, enrollment will be allowed if the treatment is ineffective or the disease has progressed during the trial and at least 5 half-lives have elapsed prior to cell collection;

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead
• Peking University People's Hospital: collaborator

MeSH Terms

Conditions

Leukemia, 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

Study Officials

• Xiangyu Zhao, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao, PhD

CONTACT

8610 88326666; Zhao_xy@bjmu.edu.cn

Fei Wu

CONTACT

+8615801390058; wufei@imunopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 17, 2024
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share