Relapsed/Refractory B-cell LymphomasPhase 1NCT06478381
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
A Phase 1 study testing L218CAR19 in people with Relapsed/Refractory B-cell Lymphomas, run by Henan Cancer Hospital at 1 site in China.
Trial summary
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory B-cell Lymphomas
- What is being tested?
- L218CAR19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at the time of inclusion
- Written informed consent
- Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received at least two lines of treatment
- With measurable disease
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 3 months or longer
- Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 6 months after the administration of study drug; Male patients must use contraception for the duration of the study and 6 months after the administration of study drug if his partner is of childbearing potential
Who cannot join
- Patients with heart disease: atrial fibrillation; History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; LVEF<50%; clinical significant pericardial effusion; Long QT syndrome
- History of severe pulmonary function impairment
- With other uncontrolled malignancy
- With active bacterial, viral, or fungal infections
- WIth uncontrolled autoimmune disease or congential immunodeficiency
- HIV antibody positive patients
Show all 18Show fewer
- Known severe hypersensitivity to biological product
- Patients with known active central nervous system (CNS) disease, including lymphoma CNS involvement
- Patients with prior CAR-T therapy
- History of allogeneic stem cell transplantation
- History of autogeneic stem cell transplantation within 6 months of screening
- History of major surgery within 4 weeks of screening
- Patients receiving live (attenuated) vaccines within 6 weeks of screening
- Pregnant or lactating women, or pregnant plan within 12 months
- Involvement of cardiac tissue by lymphoma
- with emergency due to oncothlipsis
- Unwillingness or inability to comply with the protocol
- Deemed 'unfit' by the treating physician
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 450008
Yanyan Liu, 86-037165587791, yyliu@zzu.edu.cn
Zheng Yan, 86+13598097015, zlyyyanzheng3920@zzu.edu.cn
About this study
Official title: A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of L218CAR19 in Patients With CD19 Positive Relapsed/Refractory B-cell Lymphomas
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
- Conditions
- Relapsed/Refractory B-cell Lymphomas
- Being tested
- L218CAR19
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L218CAR19Drug
L218CAR19 is intravenously administered at three dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) Receives: Drug: L218CAR19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Occurrence of DLTs
Measured: Up to 4 weeks
Treatment-emergent adverse event (AE)
Incidence of treatment-emergent AEs
Measured: Up to 1 year
Secondary outcomes (9)
Quantification of L218CAR19 in peripheral blood
To quantify L218CAR19 in a patient's peripheral blood at different time points
Measured: Up to 1 year
Time to reach Cmax (Tmax) of L218CAR19
To identify the time point when the concentration of L218CAR19 reaches maximum in a patient's peripheral blood
Measured: Up to 3 months
Area under the curve (AUC) of L218CAR19
To quantify the cumulative amount of L218CAR19 in a patient's peripheral blood over time
Measured: Up to 3 months
Clearance (CL) of L218CAR19
To determine the clearance factor of L218CAR19 in a patient's peripheral blood
Measured: Up to 3 months
Immunogenic response to L218CAR19
To evaluate the anti-drug antibodies in response to L218CAR19 administration in a patient's peripheral blood
Measured: Up to 1 year
Serum cytokine concentrations
To measure the cytokine levels (e.g. TNFa, IL-6, IL-1, IL-2, etc.) in a patient's peripheral blood at different time points
Measured: Up to 3 months
ORR
To determine the overall (best) objective anti-cancer response by Lugano criteria
Measured: Up to 1 year
PFS
To evaluate the duration of patient's progression-free survival
Measured: Up to 1 year
OS
To evaluate the overall duration of patient's survival
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-cell LymphomasStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yanyan Liu, Henan Cancer Hospital
- Investigators
- Yanyan Liu, Principal investigator, Affiliated Cancer Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478381
- Sponsor's protocol ID
- HNSZLYYML09
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of L218CAR19 in Patients With CD19 Positive Relapsed/Refractory B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT06478381
- Acronym / sponsor ID
- HNSZLYYML09
- Conditions
- Relapsed/Refractory B-cell Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jun 2024 (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.
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: L218CAR19L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years at the time of inclusion
- Written informed consent
- Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received at least two lines of treatment
- With measurable disease
- ECOG PS 0-2 at protocol entry
Key exclusion criteria (18 listed)
- Patients with heart disease: atrial fibrillation; History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; LVEF<50%; clinical significant pericardial effusion; Long QT syndrome
- History of severe pulmonary function impairment
- With other uncontrolled malignancy
- With active bacterial, viral, or fungal infections
- WIth uncontrolled autoimmune disease or congential immunodeficiency
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 |
|---|---|---|
| L218CAR19L218CAR19 is intravenously administered at three dose levels. | Drug | Dose Escalation |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Up to 4 weeks
Occurrence of DLTs
Treatment-emergent adverse event (AE)
Time frame: Up to 1 year
Incidence of treatment-emergent AEs
9 secondary outcomes
Quantification of L218CAR19 in peripheral blood
Time frame: Up to 1 year
Time to reach Cmax (Tmax) of L218CAR19
Time frame: Up to 3 months
Area under the curve (AUC) of L218CAR19
Time frame: Up to 3 months
Clearance (CL) of L218CAR19
Time frame: Up to 3 months
Immunogenic response to L218CAR19
Time frame: Up to 1 year
Serum cytokine concentrations
Time frame: Up to 3 months
ORR
Time frame: Up to 1 year
PFS
Time frame: Up to 1 year
OS
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
Yanyan Liu principal investigator
Affiliated Cancer Hospital of Zhengzhou 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 L218CAR19 in people with Relapsed/Refractory B-cell Lymphomas, run by Henan Cancer 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 8 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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 Yanyan Liu (86 037165587791, yyliu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Up to 4 weeks). 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 27 Jun 2024.