B-cell Adult Acute Lymphoblastic LeukemiaPhase 1NCT03110640
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma
A Phase 1 study testing anti-CD19 CAR-T, Fludarabine and Cyclophosphamide in people with B-cell Adult Acute Lymphoblastic Leukemia and B-cell Chronic Lymphocytic Leukemia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
- What is being tested?
- anti-CD19 CAR-T, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to Sep 2021
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 5 Years to 70 Years, Male and female;
- Expected survival > 12 weeks;
- Performance score 0-2;
- Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
- Creatinine < 2.5 mg/dl;
- ALT/AST < 3x normal;
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- Bilirubin < 2.0 mg/dl;
- Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- Take contraceptive measures before recruit to this trial;
- Written voluntary informed consent is given.
Who cannot join
- Patients with symptoms of central nervous system
- Accompanied by other malignant tumor
- Active hepatitis B or C, HIV infection
- Any other diseases could affect the outcome of this trial
- Suffering severe cardiovascular or respiratory disease
- Poorly controlled hypertension
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- A history of mental illness and poorly controlled
- Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
- Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- Reaching a steady dose if receiving anticoagulant therapy before assignment
- Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Pregnant or lactating women
- Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affilicated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Kang Yu, M.D, 55578037, yukang62@126.com
About this study
Official title: A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Read the detailed description
Primary objectives
- To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
- To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
- Conditions
- B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Hematopoietic/Lymphoid Cancer, Refractory Chronic Lymphocytic Leukemia
- Being tested
- anti-CD19 CAR-T, Fludarabine, Cyclophosphamide
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR-TBiological
Ex vivo-expanded autologous T cells modified to express CD19 CAR
FludarabineDrug
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
CyclophosphamideDrug
Patients were given cyclophosphamide 500mg/m2/day on day -4.
| Study group | Role | What they receive |
|---|---|---|
| CD9CAR-T transfer | Experimental | All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T Receives: Biological: anti-CD19 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - incidence of adverse events defined as dose-limited toxicity
incidence of adverse events defined as dose-limited toxicity
Measured: 180 days
Secondary outcomes (2)
Overall complete remission rate
Overall complete remission rate
Measured: 1 year
Duration of remission
Duration of remission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Oct 2016
- Primary completionJun 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hrain Biotechnology Co., Ltd., Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Kang YU, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Kang Yu, M.D., Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110640
- Sponsor's protocol ID
- 20170316
- Status last verified
- Nov 2019
- First submitted
- 6 Apr 2017
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dong R, Jiang S, Chen Y, Ma Y, Sun L, Xing C, Zhang S, Yu K. Prognostic Significance of Cytokine Release Syndrome in B Cell Hematological Malignancies Patients After Chimeric Antigen Receptor T Cell Therapy. J Interferon Cytokine Res. 2021 Dec;41(12):469-476. doi: 10.1089/jir.2021.0057.
PubMed 34935483
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT03110640
- Acronym / sponsor ID
- 20170316
- Conditions
- B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Hematopoietic/Lymphoid Cancer, Refractory Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Hrain Biotechnology Co., Ltd., Second Affiliated Hospital of Nanchang University
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 12 Apr 2017 (actual)
- 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 is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Detailed description
Primary objectives
- To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
- To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD9CAR-T transfer | Experimental | Biological: anti-CD19 CAR-T, Drug: Fludarabine, Drug: CyclophosphamideAll subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 5 Years to 70 Years, Male and female;
- Expected survival > 12 weeks;
- Performance score 0-2;
- Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
- Creatinine < 2.5 mg/dl;
Key exclusion criteria (13 listed)
- Patients with symptoms of central nervous system
- Accompanied by other malignant tumor
- Active hepatitis B or C, HIV infection
- Any other diseases could affect the outcome of this trial
- Suffering severe cardiovascular or respiratory disease
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 CAR-TEx vivo-expanded autologous T cells modified to express CD19 CAR | Biological | CD9CAR-T transfer |
| FludarabinePatients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2. | Drug | CD9CAR-T transfer |
| CyclophosphamidePatients were given cyclophosphamide 500mg/m2/day on day -4. | Drug | CD9CAR-T transfer |
Primary outcome
Safety - incidence of adverse events defined as dose-limited toxicity
Time frame: 180 days
incidence of adverse events defined as dose-limited toxicity
2 secondary outcomes
Overall complete remission rate
Time frame: 1 year
Duration of remission
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 34935483Dong R, Jiang S, Chen Y, Ma Y, Sun L, Xing C, Zhang S, Yu K. Prognostic Significance of Cytokine Release Syndrome in B Cell Hematological Malignancies Patients After Chimeric Antigen Receptor T Cell Therapy. J Interferon Cytokine Res. 2021 Dec;41(12):469-476. doi: 10.1089/jir.2021.0057.
- Individual participant dataSharing planned: Undecided
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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.
Kang Yu, M.D. principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site 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-T, Fludarabine and Cyclophosphamide in people with B-cell Adult Acute Lymphoblastic Leukemia and B-cell Chronic Lymphocytic Leukemia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site 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 10 inclusion and 13 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kang Yu, M.D. (55578037, yukang62@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - incidence of adverse events defined as dose-limited toxicity (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110640, which also lists 1 linked publication.
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 27 Nov 2019.