- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034446
CD19-CD22 Chimeric Antigen Receptor T (CAR-T) Cell for Treatment of B Cell Acute Lymphoblastic Leukemia (B-ALL)
August 2, 2022 updated by: wang, jianxiang, Institute of Hematology & Blood Diseases Hospital
a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL.
The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up.
The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin, China, 300020
- Institute of Hematology & Blood Diseases Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent is signed by a subject or his lineal relation.
- Age 3 and older.
- Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
Relapsed or refractory B-cell ALL
- Relapse within 12 months of first remission
- Without remission after 2 cycles of induction chemotherapy regimen.
- Without remission or relapse after salvage treatments.
- Any BM relapse after autologous stem cell transplantation (ASCT).
- Without remission or relapse after any prior CD19 targeted therapy;
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2.
Adequate organ function defined as:
- Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) ≤3 ULN;
- Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome;
- Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible.
- A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min(Cockcroft and Gault)
- Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air.
- Absolute lymphocyte count ≥0.3 x 10⁹/L.
- Women of child-bearing potential and all male participants must use highly effective methods of contraception for a period of 1 year after the CD19-CD22 CAR-T cells infusion.
Exclusion Criteria:
- Active central nervous system leukemia
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
- Major surgery within ≤ 4 weeks before enrollment.
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
Impaired cardiac function:
- Left Ventricular Ejection Fraction (LVEF) ≤45%;
- III/IV congestive heart failure (NYHA);
- Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
- Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)(QTc using Bazett's formula (QTcB)=QT/RR^0.5);
- Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
- Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
- Patients with a history of epilepsy or other active central nervous system diseases.
- Life expectancy < 12 weeks.
- Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.
- Subjects who are receiving systemic steroid treatment and who have been determined by the researchers to require long-term treatment with systemic steroids during treatment, and subjects treated with systemic steroids must be excluded < 72 hours prior to CNCT19 infusion (except inhalation or local use).
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
Single dose of CD19-CD22 CAR-T cells
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0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 24 months
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24 months
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Overall remission rate (ORR)
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of remission (DOR)
Time Frame: 24 months
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24 months
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Overall survival (OS)
Time Frame: 24 months
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24 months
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Response at Day 28 days
Time Frame: 1 month
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1 month
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Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.
Time Frame: 6 months
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6 months
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Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow
Time Frame: 6 months
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6 months
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Relapse-free survival (RFS)
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (Actual)
July 26, 2019
Study Record Updates
Last Update Posted (Actual)
August 3, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HY004001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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