- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788472
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital, College of Medicine, Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age≥15 years old; Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification; The immunophenotype of leukemia cells were CD19 and CD22 positive; Ph- or Ph- like negative; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent.
Exclusion Criteria:
History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Study Plan
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 |
---|---|
Experimental: CAR-T therapy
Administration of CD19 and CD22 CAR T-cells
|
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days after CAR-T cells infusion
|
Adverse events assessed according to NCI-CTCAE v5.0 criteria
|
Baseline up to 28 days after CAR-T cells infusion
|
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after CAR-T cells infusion
|
Incidence of treatment-emergent adverse events [Safety and Tolerability]
|
Up to 2 years after CAR-T cells infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
|
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
|
At Baseline, Month 1, 3, 6, 9 and 12
|
Complete Remission Rate
Time Frame: up to 28 days after CAR-T cells infusion
|
Complete Remission Rate after CAR-T cell therapy
|
up to 28 days after CAR-T cells infusion
|
Overall survival (OS)
Time Frame: Up to 2 years after CD19 CAR-T cells infusion
|
From the first infusion of CD19 CAR-T cells to death or the last visit
|
Up to 2 years after CD19 CAR-T cells infusion
|
Leukemia-free survival (LFS)
Time Frame: Up to 2 years after CD19 CAR-T cells infusion
|
From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
|
Up to 2 years after CD19 CAR-T cells infusion
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD19-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on B-Cell Acute Lymphoblastic Leukemia, Adult
-
National Cancer Institute (NCI)Active, not recruitingAcute Lymphoblastic Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Adult T Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | Adult L1 Acute Lymphoblastic Leukemia | Adult L2 Acute Lymphoblastic...United States
-
National Cancer Institute (NCI)CompletedB-cell Adult Acute Lymphoblastic Leukemia | Acute Undifferentiated Leukemia | Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | L1 Childhood Acute Lymphoblastic Leukemia | L2 Childhood Acute Lymphoblastic Leukemia | T-cell... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adult Lymphoblastic Lymphoma | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | B-cell Adult Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | T-cell Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Stanford UniversityNational Cancer Institute (NCI)CompletedB-cell Adult Acute Lymphoblastic Leukemia (ALL) | Ph-positive Adult Acute Lymphoblastic Leukemia (ALL) | Recurrent Adult Acute Lymphoblastic Leukemia (ALL) | T-cell Adult Acute Lymphoblastic Leukemia (ALL)United States
-
Massachusetts General HospitalMillennium Pharmaceuticals, Inc.CompletedAcute Lymphoblastic Leukemia | Lymphoblastic Lymphoma | B-cell Adult Acute Lymphoblastic Leukemia | T-cell Adult Acute Lymphoblastic LeukemiaUnited States
-
First Affiliated Hospital of Wenzhou Medical UniversitySecond Affiliated Hospital of Nanchang University; Hrain Biotechnology Co.,...UnknownHematopoietic/Lymphoid Cancer | Adult Acute Lymphoblastic Leukemia in Remission | B-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | B-cell Adult Acute Lymphoblastic LeukemiaChina
-
National Cancer Institute (NCI)M.D. Anderson Cancer CenterTerminatedRecurrent Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1United States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Adult Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | Refractory Adult Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | T Acute Lymphoblastic LeukemiaUnited States
-
KK Women's and Children's HospitalSingapore General HospitalRecruitingLymphoblastic Leukemia | Lymphoblastic Leukemia, Acute Adult | Lymphoblastic Leukemia in Children | CAR | B-cell Acute Lymphoblastic Leukemia | Large B-cell LymphomaSingapore
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAcute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic LeukemiaUnited States, Canada, Australia
Clinical Trials on CAR-T cells targeting CD19 and CD22
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingB-Cell Acute Lymphoblastic Leukemia, AdultChina
-
Hrain Biotechnology Co., Ltd.Second Affiliated Hospital of Nanchang UniversityRecruitingCentral Nervous System LymphomaChina
-
Hrain Biotechnology Co., Ltd.Ruijin HospitalNot yet recruitingAcute Lymphoblastic LeukemiaChina
-
Institute of Hematology & Blood Diseases HospitalJuventas Cell Therapy Ltd.Active, not recruitingRelapsed or Refractory B Cell Acute Lymphoblastic LeukemiaChina
-
Miltenyi Biomedicine GmbHRecruitingB-cell Lymphoma Refractory | B-cell Lymphoma Recurrent | Acute Lymphoblastic Leukemia Recurrent | Chronic Lymphocytic Leukemia Recurrent | Chronic Lymphocytic Leukemia RefractoryGermany
-
Chongqing Precision Biotech Co., LtdRecruitingLymphoma, B-Cell | Leukemia, B-cellChina
-
Miltenyi Biomedicine GmbHNot yet recruiting
-
Beijing Tongren HospitalRecruitingB-cell Lymphoma | Diffuse Large B Cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Chongqing Precision Biotech Co., LtdRecruitingLymphoma, B-Cell | Leukemia, B-cellChina
-
Hebei Senlang Biotechnology Inc., Ltd.The Second Hospital of Hebei Medical UniversityUnknown