- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271515
Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
January 19, 2021 updated by: Beijing Doing Biomedical Co., Ltd.
Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies
This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma).
Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells.
Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy.
The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
Study Type
Interventional
Enrollment (Anticipated)
20
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 Contact
- Name: gai liyun
- Phone Number: 086-13269099630
- Email: liyun_gai@doingtimes.com
Study Locations
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Hebei
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Sanhe, Hebei, China, 065200
- Hebei yanda Ludaopei Hospital
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Contact:
- Gai liyun, Docter
- Phone Number: 086-13269099630
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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
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 70 years.
- CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- Patients who have failed at least one line of a standard treatment.
- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
- Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
Exclusion Criteria:
- KPS<50.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Pregnancy and nursing females.
- HIV/HBV/HCV Infection.
- Other situations we think improper for the research.
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: conventional therapy
patients accept conventional radioactive and chemical therapy.
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EXPERIMENTAL: anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
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patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antitumor Effects
Time Frame: Every 3 months post treatment up to 24 months
|
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
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Every 3 months post treatment up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.
Time Frame: 3 years
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To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
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3 years
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Adverse events of each patient.
Time Frame: 3 years
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Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
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3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: li gangyi, Beijing Doing Biomedical Co., Ltd.
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)
March 1, 2021
Primary Completion (ANTICIPATED)
March 1, 2022
Study Completion (ANTICIPATED)
March 1, 2023
Study Registration Dates
First Submitted
August 31, 2017
First Submitted That Met QC Criteria
August 31, 2017
First Posted (ACTUAL)
September 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doing-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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Clinical Trials on anti-CD19 anti-CD20 Bispecific CAR-T
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Henan Cancer HospitalHenan Hualong Biotechnology CompanyUnknownRefractory | B-Cell Lymphoma Stage I | RelapsedChina
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Beijing Tongren HospitalRecruitingB-cell Lymphoma | Diffuse Large B Cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
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Fujian Medical UniversityRecruitingRelapsed or Refractory DLBCL Patients With Either CD19 or CD20 PositiveChina
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Shanghai Longyao Biotechnology Inc., Ltd.Xuzhou Medical University; Shanghai Jiao Tong University School of MedicineUnknownRecurrent or Refractory B Cell MalignancyChina
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First Affiliated Hospital of Zhejiang UniversityUnknown
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.Anhui Provincial HospitalRecruiting
-
Peking Union Medical College HospitalUnknown
-
Chinese PLA General HospitalUnknown
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Southwest Hospital, ChinaUnknown