Dasatinib Plus Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Ph-positive ALL Patients
NCT ID: NCT05523661
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2021-03-01
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Dasatinib plus anti-CD19/CD22 CAR-T cells
Dasatinib plus VP chemotherapy was administrated to newly diagnosed Ph-positive patients aged 55-70 years old,if hCR was achieved,autolymphocyte was collected,and anti-CD19/CD22 CAR-T cells infusion was administrated to patients followed by Fludarabine and Cyclophosphamide therapy
Interventions
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Dasatinib plus anti-CD19/CD22 CAR-T cells
Dasatinib plus VP chemotherapy was administrated to newly diagnosed Ph-positive patients aged 55-70 years old,if hCR was achieved,autolymphocyte was collected,and anti-CD19/CD22 CAR-T cells infusion was administrated to patients followed by Fludarabine and Cyclophosphamide therapy
Eligibility Criteria
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Inclusion Criteria
* (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:
1. Creatinine is in the normal range;
2. Left ventricular ejection fraction \>50%;
3. Baseline oxygen saturation\>92%;
4. Total bilirubin ≤ 1.5×ULN;
5. ALT and AST ≤ 2.5×ULN;
* (6) Able to understand and sign the Informed Consent Document
Exclusion Criteria
* (2) Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
* （3) ECOG \>=2 during CAR-T therapy
* (4) Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; Heart disease including the following condition
1. Ultrasound shows left ventricular ejection fraction \<50%;
2. stable/unstable angina,myocardia infarction
3. Baseline oxygen saturation\>92%;
4. history of pacemaker inplantation
5. more than 2 leads ST segments decrease\>1mm,or more than 2 consecutive leads T wave inversion;
6. Long QT syndrom
7. A severe arrhythmia requiring medical treatments
8. bradycardia,HR\<50BPM I.QTc\>450ms
* (5)Uncontrolled infection during screening peroid; Hemodynamic instability associated with infection,a new infection or aggravation of the original infection;new lesions on imaging;fever of unkown cause
* (6) Patients with symptoms of central nervous system;greater than grade 2 requring treatment,paralysis,aphasia,acute cerebral infarction,severe traumatic brain injury,schizophrenia
* (7)Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
* (8) HIV infection
* (9)Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
* (10) Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
* (11) allergy to Dasatinib
* (12) history of autoimmune disaese
55 Years
70 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xianmin Song, MD
principal investigator
Principal Investigators
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Xianmin Song, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai General Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Moorman AV, Harrison CJ, Buck GA, Richards SM, Secker-Walker LM, Martineau M, Vance GH, Cherry AM, Higgins RR, Fielding AK, Foroni L, Paietta E, Tallman MS, Litzow MR, Wiernik PH, Rowe JM, Goldstone AH, Dewald GW; Adult Leukaemia Working Party, Medical Research Council/National Cancer Research Institute. Karyotype is an independent prognostic factor in adult acute lymphoblastic leukemia (ALL): analysis of cytogenetic data from patients treated on the Medical Research Council (MRC) UKALLXII/Eastern Cooperative Oncology Group (ECOG) 2993 trial. Blood. 2007 Apr 15;109(8):3189-97. doi: 10.1182/blood-2006-10-051912. Epub 2006 Dec 14.
Short NJ, Kantarjian H, Jabbour E, Ravandi F. Novel Therapies for Older Adults With Acute Lymphoblastic Leukemia. Curr Hematol Malig Rep. 2018 Apr;13(2):91-99. doi: 10.1007/s11899-018-0440-3.
Other Identifiers
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HRAIN01-ALL02-POC
Identifier Type: -
Identifier Source: org_study_id