LeukemiaPhase 1NCT02546739
Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
A Phase 1 study testing Anti-CD19-CAR in people with Leukemia and Lymphoma, run by Beijing Doing Biomedical Co., Ltd. at 12 sites in China.
Trial summary
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Anti-CD19-CAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesChina
- Study dates
- 1 Mar 2021to 1 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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.
Who cannot join
- 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.
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- Pregnancy and nursing females.
- HIV/HBV/HCV Infection.
- Other situations we think improper for the research.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing DOING Biomedical Co., Ltd
Beijing, 100021
First Hospital of Jilin University
Changchun, Jilin, 130021
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Huai'An First People'S Hospital
Huaian, Jiangsu, 223300
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, 065200
Gai liyun, Doctor, 086-13269099630
Shanxi Dayi Hospital
Taiyuan, Shanxi, 030000
Tianjin people's hospital
Tianjin, Tianjin Municipality, 300121
Li gangyi, Master, 13601204100, gangyi_li@doingtimes.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Read the detailed description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ 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 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
- Being tested
- Anti-CD19-CAR
- Keywords
- Leukemia, Lymphoma, CAR T
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19-CARBiological
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 1 | Experimental | Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. Receives: Biological: Anti-CD19-CAR |
| Experimental: 2 | Experimental | Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. Receives: Biological: Anti-CD19-CAR |
| Experimental: 3 | Experimental | Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. Receives: Biological: Anti-CD19-CAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of each patient.
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 3 years
Secondary outcomes (3)
Survival time of Anti-CD19 CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Measured: 3 years
Antitumor Effects
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Measured: Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Doing Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University, Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- li gangyi, master, Study chair, Beijing Doing Biomedical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546739
- Sponsor's protocol ID
- Doing-002
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2015
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
- ClinicalTrials.gov ID
- NCT02546739
- Acronym / sponsor ID
- Doing-002
- Keywords
- Leukemia, Lymphoma, CAR T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Doing Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University, Hebei Yanda Ludaopei Hospital
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Detailed description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ 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 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: 1 | Experimental | Biological: Anti-CD19-CARAcute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
| Experimental: 2 | Experimental | Biological: Anti-CD19-CARChronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
| Experimental: 3 | Experimental | Biological: Anti-CD19-CARNon-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
Key exclusion criteria (9 listed)
- KPS<50.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- Uncontrolled active infection.
- Acute or chronic GVHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-CD19-CARCells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.) | Biological | Experimental: 1, Experimental: 2, Experimental: 3 |
Primary outcome
Adverse events of each patient.
Time frame: 3 years
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 secondary outcomes
Survival time of Anti-CD19 CAR T cells in vivo.
Time frame: 3 years
Antitumor Effects
Time frame: Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li gangyi, master study chair
Beijing Doing Biomedical Co., Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-CD19-CAR in people with Leukemia and Lymphoma, run by Beijing Doing Biomedical Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gai liyun, doctor (086-13269099630, liyun_gai@doingtimes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of each patient. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.