The Safety and Clinical Efficacy of Dasatinib Plus Human CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Subjects With Ph-positive Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

To evaluate the safety and efficacy of Dasatinib plus CD19/CD22 Bispecific CAR-T for the treatment of elderly Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given Dasatinib plus VP chemotherapy for induction treatment,if a hematologic complete remission was observed then a lymphocyte collection will be administrated to patients. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 70
Healthy Volunteers: f
View:

• (1)55 to 70 Years Old, Male and female;

• (2) Newly diagnosed Ph-positive ALL

• (3) ECOG score 0-1;

• (4) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;

• (5) Liver, kidney and cardiopulmonary functions meet the following requirements:

‣ Creatinine is in the normal range;

⁃ Left ventricular ejection fraction \>50%;

⁃ Baseline oxygen saturation\>92%;

⁃ Total bilirubin ≤ 1.5×ULN;

⁃ ALT and AST ≤ 2.5×ULN;

• (6) Able to understand and sign the Informed Consent Document

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xianmin Song, M.D.
shongxm@139.com
021-63240090
Backup
Lianghong Fang, doctor
fanghongliang@dashengbio.com
021-58552006
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 15
Treatments
Experimental: Dasatinib plus anti-CD19/CD22 CAR-T cells
Administration with oral Dasatinib plus anti-CD19/ CD22 CAR-T cells in the elderly Ph-positive ALL patients.
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov