- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902197
CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients
April 4, 2019 updated by: Xuanwu Hospital, Beijing
A Phase II Study of CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients Previously Treated With Cell Therapy
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
CD19+ B-ALL patients who have relapsed after murine-based CD19 CAR-T (CD19mCAR-T) treatment and/or have limited clinical response to CD19mCAR-T will be enrolled to receive CD19 hsCAR-T treatment.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Zhao, PhD
- Phone Number: 86-10-83198274
- Email: zhaoyu198387@gmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Children's Hospital Capital Meidcal University
-
Contact:
- Huyong Zheng, MD, PhD
-
Beijing, Beijing, China
- Recruiting
- Beijing Children's Hospital, Capital Medical University
-
Sub-Investigator:
- Yu Zhao, PhD
-
Contact:
- Huyong Zheng, MD, PhD
-
-
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
1 year to 75 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with refractory/relapse B-cell ALL with no available curative treatment options (such as autologous or allogeneic SCT);
Subjects previously treated with B cell-directed engineered cell therapy are eligible if they meet the following criteria:
- relapsed and/or MRD-positive after prior cell therapy;
- partial response to prior cell therapy;
- Clinical and laboratory data are available;
- Documented CD19 expression after previous B cell-directed therapies;
- Aged 1 to 75 years;
- KPS>40;
- At least 2 weeks or 5 drug half-lives, whichever is shorter must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy;
- Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and throughout the last follow-up visit;
- Subjects with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if the patients do not present with active GVHD and are not undergoing immunosuppressive regimes;
- Patients with CNS3 (WCB ≥5/mL in CSF with presence of lymphoblasts) disease will be eligible if the CNS disease is responsive to therapy;
- Participation in the clinical trials should be voluntary with signed informed consent.
Exclusion Criteria:
- Patients with hypervolemia (white blood cell count> 50 x 10^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
- History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
- Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
- Patients with positive results for HIV, HBV, HCV tests;
- With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma;
- Patients that are receiving anticoagulant therapy or have ever coagulation disorders;
- Any medical condition that in the judgment of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study;
- History of severe immediate hypersensitivity reaction to any of the agents used in this study;
- Female patients who are pregnant or breastfeeding;
- Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 co-stimulation;
- Patients with any uncontrolled diseases that are unsuitable for enrollment;
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity;
- Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study;
- Patients who have been enrolled in other clinical studies.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CD19 hsCAR-T
This cohort will be administrated by T cells transduced with lentivirus vectors expressing CD19 hsCAR
|
CD19 hsCAR-T will be administered by I.V. infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) within 3 months
Time Frame: 3 months
|
Overall response rate (ORR) within 3 months after infusion of CD19 hsCAR-T
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best overall response (BOR)
Time Frame: 3 months
|
Best overall response (BOR) of complete remission (CR) or CR with incomplete blood count recovery (CRi) within 3 months after CD19 hsCAR-T infusion
|
3 months
|
Duration of remission (DoR)
Time Frame: 1 year
|
Duration of remission (DoR) within 1 year after CD19 hsCAR-T infusion (Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL)
|
1 year
|
Event free survival within 1 year
Time Frame: 1 year
|
Event free survival within 1 year (Event free survival is defined as the time from start of the first infusion to the earliest of death from any cause or relapse)
|
1 year
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time Frame: 6 months
|
Safety and tolerability of CD19 hsCAR-T: frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Huyong Zheng, MD, PhD, Beijing Children's Hospital
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 (ANTICIPATED)
April 22, 2019
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
December 21, 2023
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 1, 2019
First Posted (ACTUAL)
April 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD19hsCAR20190401
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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