B Cell LeukemiaPhase 1NCT03383952
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
A Phase 1 study testing ICAR19 CAR-T cells in people with B Cell Leukemia and B Cell Lymphoma, run by Immune Cell, Inc. at 1 site in China.
Trial summary
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- B Cell Leukemia, B Cell Lymphoma
- What is being tested?
- ICAR19 CAR-T cells
- 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 Mar 2017to 31 Dec 2025
- 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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- survival>12 weeks;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- LVEF≥50%;
- Creatinine<2.5mg/dl;
- Bilirubin<2.5mg/dl;
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- ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
- At least 7 days after last chemotherapy;
- provide with informed consent.
Who cannot join
- Active clinically significant CNS dysfunction
- Pregnant or breast-feeding women.
- Uncontrolled active infection including hepatitis B or C.
- HIV positive.
- Use of systemic steroids within 72 hours.
- Allogeneic lymphocyte treatments within recent 6 months.
- Any uncontrolled active medical disorder.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Xiulian Sun, MD.,Ph.D, (+86) 010-62420659, xiuliansun@ymcell.com
xuehong Ran, doctor, 0536-8192117, ranxuehong1967@163.com
About this study
Official title: A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
- Conditions
- B Cell Leukemia, B Cell Lymphoma
- Being tested
- ICAR19 CAR-T cells
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICAR19 CAR-T cellsBiological
Also called Biological drug
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
| Study group | Role | What they receive |
|---|---|---|
| ICAR19 CAR-T cells | Experimental | Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells. Receives: Biological: ICAR19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the safety of ICAR19 CAR-T cells
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
Measured: 2 years
Secondary outcomes (2)
Measure the anti-tumor effect of ICAR19 CAR-T cells
Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma
Measured: 3 years
Survival time of ICAR19 T cells in vivo.
To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Cell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weifang People's Hospital
- Responsible party
- Principal investigator, Xiulian Sun, Immune Cell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383952
- Sponsor's protocol ID
- CD19 Targeted CAR-T
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
- ClinicalTrials.gov ID
- NCT03383952
- Acronym / sponsor ID
- CD19 Targeted CAR-T
- Conditions
- B Cell Leukemia, B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Immune Cell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Weifang People's Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Dec 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.
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICAR19 CAR-T cells | Experimental | Biological: ICAR19 CAR-T cellsImmunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- survival>12 weeks;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- LVEF≥50%;
- Creatinine<2.5mg/dl;
Key exclusion criteria (7 listed)
- Active clinically significant CNS dysfunction
- Pregnant or breast-feeding women.
- Uncontrolled active infection including hepatitis B or C.
- HIV positive.
- Use of systemic steroids within 72 hours.
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 |
|---|---|---|
| ICAR19 CAR-T cellsAlso: Biological drugT cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage. | Biological | ICAR19 CAR-T cells |
Primary outcome
Measure the safety of ICAR19 CAR-T cells
Time frame: 2 years
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
2 secondary outcomes
Measure the anti-tumor effect of ICAR19 CAR-T cells
Time frame: 3 years
Survival time of ICAR19 T cells in vivo.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
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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.
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 ICAR19 CAR-T cells in people with B Cell Leukemia and B Cell Lymphoma, run by Immune Cell, Inc. 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 9 inclusion and 7 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 Dec 2017. 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 Xiulian Sun, MD.,Ph.D ((+86) 010-62420659, xiuliansun@ymcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the safety of ICAR19 CAR-T cells (time frame: 2 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 27 Dec 2017.