Non-hodgkin's LymphomaNCT04447547
Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
A study testing CD19 CAR-T in people with Non-hodgkin's Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 2 sites in China.
Trial summary
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Non-hodgkin's Lymphoma
- What is being tested?
- CD19 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jun 2020to 30 Dec 2022
- Phase
- Interventional
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
- There should be at least one measurable tumor focus according to the RECIST version 1.1;
- ECOG Scores: 0~2;
- The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
- Estimated survival time was longer than 3 months;
- main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation >92%；
- Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
Who cannot join
- Serious cardiac insufficiency；
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C virus infection;
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- Patients with HIV infection or syphilis infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Participated in any other clinical drug trial for the last six months;
- Being pregnant and lactating or having pregnancy within 12 months;
- With other uncontrolled diseases and considered not suitable to participate by the researchers;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
BeiJing Ludaopei Hospital
Beijing, Yizhuang, 100000
Peihua Lu, PhD&MD, 008618611636172, peihua_lu@126.com
Peihua Lu, PhD&MD
- Recruiting
He bei Yan da Lu dao pei Hospital
Yanda
Peihua Lu
About this study
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
Read the detailed description
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.
- Conditions
- Non-hodgkin's Lymphoma
- Being tested
- CD19 CAR-T
- Keywords
- NHL，CD19
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-TBiological
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
| Study group | Role | What they receive |
|---|---|---|
| SL1904B CAR-T | Experimental | Patients will be treated with CD19 CAR-T cells Receives: Biological: CD19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (4)
Efficacy:duration of response (DOR)
duration of response (DOR)
Measured: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method
Measured: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Measured: First month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, PhD&MD, Principal investigator, Beijing Lu Daopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447547
- Sponsor's protocol ID
- 1904B for NHL
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04447547
- Acronym / sponsor ID
- 1904B for NHL
- Conditions
- Non-hodgkin's Lymphoma
- Keywords
- NHL，CD19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Lu Daopei Hospital, Hebei Yanda Ludaopei Hospital
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Jun 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 is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
Detailed description
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL1904B CAR-T | Experimental | Biological: CD19 CAR-TPatients will be treated with CD19 CAR-T cells |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
- There should be at least one measurable tumor focus according to the RECIST version 1.1;
- ECOG Scores: 0~2;
- The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
Key exclusion criteria (12 listed)
- Serious cardiac insufficiency；
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
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 |
|---|---|---|
| CD19 CAR-TBiological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis; | Biological | SL1904B CAR-T |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Overall Remission Rate (ORR)
Time frame: 3 months post CAR-T cells infusion
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B
4 secondary outcomes
Efficacy:duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Time frame: First month post CAR-T cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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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.
Peihua Lu, PhD&MD principal investigator
Beijing Lu Daopei Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD19 CAR-T in people with Non-hodgkin's Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 2 sites 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 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Peihua Lu, PhD&MD (008618611636172, peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First month post 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 29 Sep 2020.