Refractory B-Cell Non-Hodgkin LymphomaPhase 1NCT04684472
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
A Phase 1 study testing Modified anti-CD19 CAR T cells in people with Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Leukemia, run by Liqun Zou at 1 site in China.
Trial summary
This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Leukemia
- What is being tested?
- Modified anti-CD19 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2021to 1 Jan 2024
- 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
- Male or female aged 18-70 years;
- Estimated survival time ≥ 12 weeks;
- Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
- Ineffectively or relapses after 2 or more remedial treatments
- Relapse after auto-HSCT or unsuitable for auto-HSCT;
- At least one assessable tumor lesion;
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- ECOG performance status 0 to 2;
- Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
- Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Who cannot join
- Patients with other uncontrolled malignancies;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
- Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
- Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
- Patients with atrial or ventricular involvement by B-cell malignancies;
- Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
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- Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;
- Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;
- Any situations that the investigators believes were not suitable for this trial;
- Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
- Pregnant(or lactation) women;
- Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan University
Chengdu, Sichuan
weiming li
About this study
Official title: Phase I, Open Label, Study of CXCR4 Modified CD19 CAR-T Therapy in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).
- Being tested
- Modified anti-CD19 CAR T cells
- Keywords
- Modified CD19 CAR-T
- Medical subject headings
- Lymphoma, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified anti-CD19 CAR T cellsBiological
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Modified anti-CD19 CAR T cell therapy | Experimental | CAR T cell therapy Receives: Biological: Modified anti-CD19 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Up to 5 years after modified CD19 CAR-T cells infusion
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after modified CD19 CAR-T cells infusion
Secondary outcomes (4)
B-cell malignancies, Overall response rate(ORR)
Assessment of ORR(ORR=CR+PR)
Measured: 3 months, 6 months
B-cell malignancies, Overall survival
From the first infusion of modified CD19 CAR-T cells to death or the last visit
Measured: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, progression-free survival（PFS）
From the first infusion of modified CD19 CAR-T cells to the occurrence of any event, including death, relapse, disease progression, and the last visit
Measured: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, disease control rate (DCR)
Assessment of DCR(DCR=CR+PR+SD)
Measured: Month 6,12,18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start17 Mar 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory B-Cell Non-Hodgkin LymphomaStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liqun Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liqun Zou, Sichuan University
- Investigators
- liqun zou, phd, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684472
- Sponsor's protocol ID
- MCART-003
- Status last verified
- Sep 2022
- First submitted
- 21 Dec 2020
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Study of CXCR4 Modified CD19 CAR-T Therapy in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
- ClinicalTrials.gov ID
- NCT04684472
- Acronym / sponsor ID
- MCART-003
- Keywords
- Modified CD19 CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Liqun ZouUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Dec 2020 (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 study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified anti-CD19 CAR T cell therapy | Experimental | Biological: Modified anti-CD19 CAR T cellsCAR T cell therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18-70 years;
- Estimated survival time ≥ 12 weeks;
- Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
- At least one assessable tumor lesion;
- ECOG performance status 0 to 2;
Key exclusion criteria (12 listed)
- Patients with other uncontrolled malignancies;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
- Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
- Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
- Patients with atrial or ventricular involvement by B-cell malignancies;
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 |
|---|---|---|
| Modified anti-CD19 CAR T cellsintravenous infusion | Biological | Modified anti-CD19 CAR T cell therapy |
Primary outcome
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time frame: Up to 5 years after modified CD19 CAR-T cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after modified CD19 CAR-T cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
4 secondary outcomes
B-cell malignancies, Overall response rate(ORR)
Time frame: 3 months, 6 months
B-cell malignancies, Overall survival
Time frame: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, progression-free survival（PFS）
Time frame: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, disease control rate (DCR)
Time frame: Month 6,12,18 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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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.
liqun zou, phd principal investigator
Sichuan 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 Modified anti-CD19 CAR T cells in people with Refractory B-Cell Non-Hodgkin Lymphoma and Refractory Leukemia, run by Liqun Zou 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 12 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 Sep 2022. 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 pei shu, MD (+86(028)85423525, peishu1991@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events [Safety and Tolerability] (time frame: Up to 5 years after modified CD19 CAR-T cells infusion). The study lists 2 primary outcomes in all. 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 Sep 2022.