- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260945
CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients
March 6, 2022 updated by: Hebei Yanda Ludaopei Hospital
CD19/CD20 Dual-CAR-T for Patients With B-cell Leukemia
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell leukemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell leukemia.
Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells.
Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored.
The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell leukemia.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- 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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Hebei
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Sanhe, Hebei, China, 065200
- Hebei yanda Ludaopei 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
1 year to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Relapsed and refractory B-cell acute malignancies with:
- Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
- MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
- Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
- Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
- Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
- Double positive expression of CD19 / CD20 in B cells;
- Ages 1 to 70 years, including boundary values;
- ECOG score 0-3 points;
- Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
Exclusion Criteria:
patients with organ failure:
- Heart: NYHA heart function grade IV;
- Liver: Grade C that achieves Child-Turcotte liver function grading;
- Kidney: kidney failure and uremia;
- Lung: symptoms of respiratory failure;
- Brain: a person with a disability;
- Active infections that are difficult to control;
- Human immunodeficiency virus (HIV) positive;
- Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
- GVHD ≥ 2 or anti-GVHD treatment;
- Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;
- Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
- Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
- intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
- pregnant or lactating women;
- The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
- Patients who participate in other clinical studies at the same time;
- The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
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 |
---|---|
Experimental: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection.
5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
|
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection.
5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with adverse events.
Time Frame: 6 months
|
6 months
|
|
Objective remission rate(ORR)
Time Frame: 6 months
|
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-Free Survival(RFS )
Time Frame: 6 months
|
6 months
|
Overall-Survival(OS)
Time Frame: 6 months
|
6 months
|
Persistence of CAR-T cells in vivo
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 10, 2020
Primary Completion (Actual)
October 10, 2021
Study Completion (Actual)
February 10, 2022
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 7, 2020
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 6, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HXYT-007
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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