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Status unknownNCT05523661Updated Nov 28, 2023

Dasatinib Plus Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Ph-positive ALL Patients

A Phase 1 interventional study of Dasatinib plus anti-CD19/CD22 CAR-T cells in Ph Positive ALL, CAR-T Cell and Dasatinib, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2021, registered Nov 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
55 Years to 70 Years
Sex
All
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Study 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

Read the detailed description

Newly diagnosed ph-positive ALL patients over 60 and less than 70 years old will be enrolled. Patients will be given Dasatinib plus VP chemotherapy for induction remission 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

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Conditions studied

  • Ph Positive ALL
  • CAR-T Cell
  • Dasatinib

Keywords

  • CD19/CD22 Bispecific CAR-T
  • Ph-positive lymphoblastic leukemia
  • Dasatinib
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In context

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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:

    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

Exclusion Criteria:

  • (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

    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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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.

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

Interventions

  • DrugDasatinib 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

06

What researchers measure

Primary outcomes

  1. Number of patients achieving molecular CR

    number of patients achieving molecular CR

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

Secondary outcomes

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

    Overall survival for all patients enrolled

    Time frame: 2-year OS

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

    Relapse free survival for all patients enrolled

    Time frame: 2-year RFS

  3. Number of patients achieving molecular CR

    number of patients achieving molecular CR after infusion of Anti-CD19/CD22 CAR-T cells

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 17170120 ↗
  • 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. PubMed 29423571 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Mar 2025, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2021
First posted
Aug 31, 2022
StartActual
Mar 1, 2021
Primary completionEst.
Mar 1, 2025
CompletionEst.
Sep 1, 2025
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05523661
Responsible party
Xianmin Song, MD (principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 31, 2022
Start date
Mar 1, 2021
Primary completion
Mar 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Nov 28, 2023

Study contacts

Xianmin Song, M.D.
Contact
shongxm@139.com
021-63240090
Lianghong Fang, doctor
Contact
fanghongliang@dashengbio.com
021-58552006
Xianmin Song, M.D.
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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