Lymphoma LeukemiaNCT03811457
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
A study testing Welgenaleucel in people with Lymphoma Leukemia, run by UWELL Biopharma at 1 site in China.
Trial summary
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma Leukemia
- What is being tested?
- Welgenaleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
- Absolute lymphocyte count, ALC )≧600/μl
- HIV, HTLV, Syphilis negative
- GPT ≦200 U/L
- Cr ≦221 umol/L
- Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- Voluntary informed consent is given.
Who cannot join
- Body weight < 20Kg
- Pregnant women.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene or cell therapy products.
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- Any uncontrolled active medical disorder that would preclude participation as outlined.
- Expected survival< 12 weeks
- Received investigational drug or device within 30 days pre-trial;
- Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.
Trial locations and contacts
1 site in 1 country.
About this study
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
- Conditions
- Lymphoma Leukemia
- Being tested
- Welgenaleucel
- Keywords
- CAR-T cell, CD19, Lymphoma, Leukemia
- Medical subject headings
- Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WelgenaleucelGenetic
Also called UWC19
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
| Study group | Role | What they receive |
|---|---|---|
| Welgenaleucel (UWC19) | Experimental | The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times Receives: Genetic: Welgenaleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse events associated with CAR T cell product infusions are assessed.
The type, frequency, severity, and duration of adverse events will be summarized
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- UWELL Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liaocheng People's Hospital
- Responsible party
- Sponsor
- Investigators
- Cheng-Yi Kuo, PhD, Study director, UWELL Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811457
- Sponsor's protocol ID
- UCAR019
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT03811457
- Acronym / sponsor ID
- UCAR019
- Conditions
- Lymphoma Leukemia
- Keywords
- CAR-T cell, CD19, Lymphoma, Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- UWELL BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Liaocheng People's Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Jan 2019 (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.
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Welgenaleucel (UWC19) | Experimental | Genetic: WelgenaleucelThe Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
- Absolute lymphocyte count, ALC )≧600/μl
- HIV, HTLV, Syphilis negative
- GPT ≦200 U/L
- Cr ≦221 umol/L
Key exclusion criteria (10 listed)
- Body weight < 20Kg
- Pregnant women.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
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 |
|---|---|---|
| WelgenaleucelAlso: UWC19Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19. | Genetic | Welgenaleucel (UWC19) |
Primary outcome
The adverse events associated with CAR T cell product infusions are assessed.
Time frame: 30 days
The type, frequency, severity, and duration of adverse events will be summarized
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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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.
Cheng-Yi Kuo, PhD study director
UWELL Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Welgenaleucel in people with Lymphoma Leukemia, run by UWELL Biopharma 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 22 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adverse events associated with CAR T cell product infusions are assessed. (time frame: 30 days). 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 22 Jan 2019.