NCT05523661

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

November 14, 2021

Last Update Submit

November 26, 2023

Conditions

Ph Positive ALLCAR-T CellDasatinib

Keywords

CD19/CD22 Bispecific CAR-TPh-positive lymphoblastic leukemiaDasatinib

Outcome Measures

Primary Outcomes (1)

  • Number of patients achieving molecular CR

    number of patients achieving molecular CR

    3 months after infusion of Anti-CD19/CD22 CAR-T cells

Secondary Outcomes (3)

  • OS for patients receiving infusion of anti-CD19/CD22 CAR-T cells

    2-year OS

  • RFS for patients receiving infusion of anti-CD19/CD22 CAR-T cells

    2-year RFS

  • Number of patients achieving molecular CR

    6 months after infusion of Anti-CD19/CD22 CAR-T cells

Study Arms (1)

Dasatinib plus anti-CD19/CD22 CAR-T cells

EXPERIMENTAL

Administration with oral Dasatinib plus anti-CD19/ CD22 CAR-T cells in the elderly Ph-positive ALL patients.

Drug: Dasatinib plus anti-CD19/CD22 CAR-T cells

Interventions

Dasatinib plus anti-CD19/CD22 CAR-T cellsDRUG

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

Dasatinib plus anti-CD19/CD22 CAR-T cells

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (1) Disease relapse;
  • (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
  • Ultrasound shows left ventricular ejection fraction \<50%;
  • stable/unstable angina,myocardia infarction
  • Baseline oxygen saturation\>92%;
  • history of pacemaker inplantation
  • more than 2 leads ST segments decrease\>1mm,or more than 2 consecutive leads T wave inversion;
  • Long QT syndrom
  • A severe arrhythmia requiring medical treatments
  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17170120BACKGROUND

  • 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.

    PMID: 29423571BACKGROUND

MeSH Terms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Xianmin Song, M.D.

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianmin Song, M.D.

CONTACT

021-63240090shongxm@139.com

Lianghong Fang, doctor

CONTACT

021-58552006fanghongliang@dashengbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 14, 2021

First Posted

August 31, 2022

Study Start

March 1, 2021

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)