B-Cell LeukemiaPhase 1/2NCT05932173
A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
A Phase 1/2 study testing Anti-CD19 Autologous CAR-T Cell Infusion in people with B-Cell Leukemia and B-Cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
- What is being tested?
- Anti-CD19 Autologous CAR-T Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2025
- 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
- A definite diagnosis of relapsed/refractory B-cell malignancies;
- Male or female, aged 2-75 years;
- Confirmed detectable disease；
- Expected survival time >12 weeks;
- Eastern cooperative oncology group (ECOG) score is 0-2;
- Adequate liver , kidney and cardiopulmonary function;
- 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;
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
Who cannot join
- Presence of other concurrent active malignancy; People with severe mental disorders;
- 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;
- 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;
- 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;
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- 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 UCAR-T cell reinfusion, except for adverse events;
- Receiving donor lymphocyte infusion within 6 weeks before enrollment;
- Pregnant and lactating women;
- Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650100
Lihua Zhang, 64774204 ext. +0871, zhanglihua95@126.com
Sanbin Wang, MD
About this study
Official title: An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.
Read the detailed description
OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells 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 Leukemia, B-Cell Lymphoma, B-cell Tumors
- Being tested
- Anti-CD19 Autologous CAR-T Cell Infusion
- Keywords
- B Cell, CAR-T, CD19, Leukemia, Lymphoma
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 Autologous CAR-T Cell InfusionBiological
Also called OlyCAR-019
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
| Study group | Role | What they receive |
|---|---|---|
| OlyCAR-019 Cell Infusion | Experimental | OlyCAR-019 cell infusion will be administered by vein after short-time manufacture. Receives: Biological: Anti-CD19 Autologous CAR-T Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Up to 12 months after infusion
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Measured: Up to 28 days after infusion
Secondary outcomes (2)
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Measured: Up to 3 months after infusion
Progression-free survival(PFS)
Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause.
Measured: Up to 3 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive one of the three doses of 0.5-2\*10\^6/kg, 3-4\*10\^6/kg, 5-6\*10\^6/kg.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Professor, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932173
- Sponsor's protocol ID
- KM-PBC920
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT05932173
- Acronym / sponsor ID
- KM-PBC920
- Conditions
- B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
- Keywords
- B Cell, CAR-T, CD19, Leukemia, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Jul 2023 (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.
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.
Detailed description
OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells 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
- Model description
- Patients will receive one of the three doses of 0.5-2*10^6/kg, 3-4*10^6/kg, 5-6*10^6/kg.
| Arm | Type | Receives |
|---|---|---|
| OlyCAR-019 Cell Infusion | Experimental | Biological: Anti-CD19 Autologous CAR-T Cell InfusionOlyCAR-019 cell infusion will be administered by vein after short-time manufacture. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- A definite diagnosis of relapsed/refractory B-cell malignancies;
- Male or female, aged 2-75 years;
- Confirmed detectable disease；
- Expected survival time >12 weeks;
- Eastern cooperative oncology group (ECOG) score is 0-2;
Key exclusion criteria (14 listed)
- Presence of other concurrent active malignancy; People with severe mental disorders;
- 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;
- 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;
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 Autologous CAR-T Cell InfusionAlso: OlyCAR-019Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform | Biological | OlyCAR-019 Cell Infusion |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: Up to 12 months after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
MTD
Time frame: Up to 28 days after infusion
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 3 months after infusion
Progression-free survival(PFS)
Time frame: Up to 3 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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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.
Sanbin Wang, Professor principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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 Anti-CD19 Autologous CAR-T Cell Infusion in people with B-Cell Leukemia and B-Cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 8 inclusion and 14 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 11 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanbin Wang, Professor (13187424131 ext. +86, Sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: Up to 12 months after 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 11 Jul 2023.