B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT05571540
Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL
A Phase 1/2 study testing U-CAR-T Cells (LstCAR019) in people with B-cell Acute Lymphoblastic Leukemia and B-ALL, run by Kunming Hope of Health Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL). Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, B-ALL
- What is being tested?
- U-CAR-T Cells (LstCAR019)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2024
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, aged 2-75 years;
- A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes >5% in bone marrow at baseline (flow cytometry);
- CD19 expression was positive in bone marrow or peripheral blood tumor cells;
- ECOG score 0-2 points;
- Expected survival time ≥3 months;
- Adequate liver, kidney, heart and lung function;
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- Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart;
- Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
- Voluntarily sign the informed consent.
Who cannot join
- Presence of other concurrent active malignancy;
- People with severe mental disorders;
- A history of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
- Acute GVHD of grade II-IV or extensive chronic GVHD;
- Had grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
- The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
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- A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
- Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;
- Patients with severe history of allergy or allergic constitution;
- A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years;
- Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
- Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
- Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
- Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after LstCAR019 cell reinfusion, except for adverse events;
- Receiving donor lymphocyte infusion within 6 weeks before enrollment;
- Pregnant and lactating women;
- Any other condition that the investigator deemed inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)
This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
Read the detailed description
Although the anti-CD19 CAR-T cell therapies have gained significant clinical outcome in patients with r/r B-ALL，autologous CAR-T is not feasible for some patients. To make further improvement, the investigators are going to conduct a clinical trial using universal CAR-T cells(LstCAR019) targeting CD19 for r/r B-ALL patients.
After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the LstCAR019 will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, B-ALL
- Being tested
- U-CAR-T Cells (LstCAR019)
- Keywords
- universal CAR-T, CD19
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-CAR-T Cells (LstCAR019)Biological
LstCAR019 will be administered by vein. The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set:Dose level one: 1×10^6 cells/kg;Dose level two: 2×10^6 cells/kg;Dose level three: 5×10^6 cells/kg. Each dose group requires at least three subjects. The trial will start from dose level one. The second portion includes a dosage extended cohort and will start after the finish of the"3+3"dose escalation study. Twelve subjects will get infusion of LstCAR019 at the best dose verified in the first portion.
| Study group | Role | What they receive |
|---|---|---|
| U-CAR-T Cells (LstCAR019) | Experimental | Subjects who meet the enrollment conditions will receive intravenous infusion of U-CAR-T Cells (LstCAR019) after lymphodepletion. Receives: Biological: U-CAR-T Cells (LstCAR019) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Neurotoxicity and/or CRS≥G3.
Measured: Up to 28 days after LstCAR019 infusion
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Up to 12 months after LstCAR019 infusion
Secondary outcomes (5)
Persistence of CAR-T cells
The persistence over time of CAR-T cells in the peripheral blood as determined by flow cytometry and qPCR.
Measured: Up to 24 weeks after infusion
Objective response rate (ORR)
Patients who achieve CR(complete response) or CRi after infusion
Measured: At 4 ,8 , 12 weeks after infusion
Progression-free survival (PFS)
Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.
Measured: Up to 24 weeks after infusion
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Measured: Up to 24 weeks after infusion
Duration of remission (DOR)
Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.
Measured: Up to 24 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: The PI decides to stop.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Hope of Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Principal investigator, Kunming Hope of Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571540
- Sponsor's protocol ID
- PBC049
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 30 Nov 2022
- 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)
- ClinicalTrials.gov ID
- NCT05571540
- Acronym / sponsor ID
- PBC049
- Conditions
- B-cell Acute Lymphoblastic Leukemia, B-ALL
- Keywords
- universal CAR-T, CD19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI decides to stop.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kunming Hope of Health HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 7 Oct 2022 (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, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
Detailed description
Although the anti-CD19 CAR-T cell therapies have gained significant clinical outcome in patients with r/r B-ALL，autologous CAR-T is not feasible for some patients. To make further improvement, the investigators are going to conduct a clinical trial using universal CAR-T cells(LstCAR019) targeting CD19 for r/r B-ALL patients.
After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the LstCAR019 will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U-CAR-T Cells (LstCAR019) | Experimental | Biological: U-CAR-T Cells (LstCAR019)Subjects who meet the enrollment conditions will receive intravenous infusion of U-CAR-T Cells (LstCAR019) after lymphodepletion. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, aged 2-75 years;
- A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes >5% in bone marrow at baseline (flow cytometry);
- CD19 expression was positive in bone marrow or peripheral blood tumor cells;
- ECOG score 0-2 points;
- Expected survival time ≥3 months;
Key exclusion criteria (18 listed)
- Presence of other concurrent active malignancy;
- People with severe mental disorders;
- A history of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
- Acute GVHD of grade II-IV or extensive chronic GVHD;
- Had grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
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 |
|---|---|---|
| U-CAR-T Cells (LstCAR019)LstCAR019 will be administered by vein. The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set:Dose level one: 1×10^6 cells/kg;Dose level two: 2×10^6 cells/kg;Dose level three: 5×10^6 cells/kg. Each dose group requires at least three subjects. The trial will start from dose level one. The second portion includes a dosage extended cohort and will start after the finish of the"3+3"dose escalation study. Twelve subjects will get infusion of LstCAR019 at the best dose verified in the first portion. | Biological | U-CAR-T Cells (LstCAR019) |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days after LstCAR019 infusion
Neurotoxicity and/or CRS≥G3.
Incidence of Treatment Related adverse events (AEs)
Time frame: Up to 12 months after LstCAR019 infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
5 secondary outcomes
Persistence of CAR-T cells
Time frame: Up to 24 weeks after infusion
Objective response rate (ORR)
Time frame: At 4 ,8 , 12 weeks after infusion
Progression-free survival (PFS)
Time frame: Up to 24 weeks after infusion
Overall survival (OS)
Time frame: Up to 24 weeks after infusion
Duration of remission (DOR)
Time frame: Up to 24 weeks after infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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 Li, MD principal investigator
Kunming Hope of Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing U-CAR-T Cells (LstCAR019) in people with B-cell Acute Lymphoblastic Leukemia and B-ALL, run by Kunming Hope of Health Hospital 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 18 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: withdrawn, as of the sponsor's last update on 30 Nov 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose-limiting toxicity (DLT) (time frame: Up to 28 days after LstCAR019 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 30 Nov 2022.