Ph Positive ALLPhase 1NCT05523661
Dasatinib Plus Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for Elderly Ph-positive ALL Patients
A Phase 1 study testing Dasatinib plus anti-CD19/CD22 CAR-T cells in people with Ph Positive ALL and CAR-T Cell, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Ph Positive ALL, CAR-T Cell, Dasatinib
- What is being tested?
- Dasatinib plus anti-CD19/CD22 CAR-T cells
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
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- 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
Who cannot join
- (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
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- 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;
- (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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai
Xianmin Song, M.D., 021-63240090, shongxm@139.com
Lianghong Fang, doctor, 02158552006, fanghongliang@dashengbio.com
About this study
Official title: 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
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
- Conditions
- Ph Positive ALL, CAR-T Cell, Dasatinib
- Being tested
- Dasatinib plus anti-CD19/CD22 CAR-T cells
- Keywords
- CD19/CD22 Bispecific CAR-T, Ph-positive lymphoblastic leukemia, Dasatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dasatinib plus anti-CD19/CD22 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients achieving molecular CR
number of patients achieving molecular CR
Measured: 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
Overall survival for all patients enrolled
Measured: 2-year OS
RFS for patients receiving infusion of anti-CD19/CD22 CAR-T cells
Relapse free survival for all patients enrolled
Measured: 2-year RFS
Number of patients achieving molecular CR
number of patients achieving molecular CR after infusion of Anti-CD19/CD22 CAR-T cells
Measured: 6 months after infusion of Anti-CD19/CD22 CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Mar 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ph Positive ALLStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523661
- Sponsor's protocol ID
- HRAIN01-ALL02-POC
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17170120Short 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05523661
- Acronym / sponsor ID
- HRAIN01-ALL02-POC
- Conditions
- Ph Positive ALL, CAR-T Cell, Dasatinib
- Keywords
- CD19/CD22 Bispecific CAR-T, Ph-positive lymphoblastic leukemia, Dasatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib plus anti-CD19/CD22 CAR-T cells | Experimental | Drug: Dasatinib plus anti-CD19/CD22 CAR-T cellsAdministration with oral Dasatinib plus anti-CD19/ CD22 CAR-T cells in the elderly Ph-positive ALL patients. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (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:
Key exclusion criteria (20 listed)
- (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
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib plus anti-CD19/CD22 CAR-T cellsDasatinib 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 | Drug | Dasatinib plus anti-CD19/CD22 CAR-T cells |
Primary outcome
Number of patients achieving molecular CR
Time frame: 3 months after infusion of Anti-CD19/CD22 CAR-T cells
number of patients achieving molecular CR
3 secondary outcomes
OS for patients receiving infusion of anti-CD19/CD22 CAR-T cells
Time frame: 2-year OS
RFS for patients receiving infusion of anti-CD19/CD22 CAR-T cells
Time frame: 2-year RFS
Number of patients achieving molecular CR
Time frame: 6 months after infusion of Anti-CD19/CD22 CAR-T cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 17170120Moorman 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.
- Background: PubMed 29423571Short 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianmin Song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib plus anti-CD19/CD22 CAR-T cells in people with Ph Positive ALL and CAR-T Cell, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianmin Song, M.D. (021-63240090, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients achieving molecular CR (time frame: 3 months after infusion of Anti-CD19/CD22 CAR-T cells). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.