LeukemiaNCT04610125
Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
A study testing Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis in people with Leukemia and Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is an open, single-arm, prospective，clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- What is being tested?
- Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2020to 22 Jun 2025
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sign the informed consent 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;
- Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
- Age: 1-18 years (including boundary value), both male and female;
- Subjects with Lansky score ≥ 50;
- The results of treatment-related antigens were positive;
- The expected survival time is more than 3 months from the date of signing the informed consent.
Who cannot join
- Severe cardiac insufficiency and left ventricular ejection fraction < 50%;
- He had a history of severe lung function damage;
- Combined with other advanced malignant tumors;
- Severe infection was found and could not be effectively controlled;
- With metabolic diseases (except diabetes mellitus);
- Combined with severe autoimmune disease or congenital immunodeficiency;
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- Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [HCV AB] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- Severe allergy history of biological products (including antibiotics);
- Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
- The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pediatric hematology, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Lian Jiang, MD
Lian Jiang, MD
About this study
This is an open, single-arm, prospective，clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Read the detailed description
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.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.
- Being tested
- Auto CAR-T, Cyclophosphamide,Fludarabine, Leukapheresis
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto CAR-TBiological
Biological: Auto CAR-T
Cyclophosphamide,FludarabineDrug
Drug: Cyclophosphamide,Fludarabine
LeukapheresisProcedure or surgery
Leukapheresis
| Study group | Role | What they receive |
|---|---|---|
| Auto CAR-T | Experimental | Patients will be treated with Auto CAR-T cells Receives: Biological: Auto CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis |
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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First month post CAR-T cells infusion
Efficacy: Remission Rate
Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD)
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start23 Jun 2020
- Primary completion22 Jun 2023 (estimated)
- Study completion22 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Responsible party
- Sponsor
- Investigators
- Lian Jiang, MD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610125
- Sponsor's protocol ID
- Children CAR-T
- Status last verified
- Aug 2020
- First submitted
- 26 Oct 2020
- Last updated
- 30 Oct 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 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
- ClinicalTrials.gov ID
- NCT04610125
- Acronym / sponsor ID
- Children CAR-T
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 22 Jun 2025 (estimated)
- First posted
- 30 Oct 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 an open, single-arm, prospective，clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Detailed description
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auto CAR-T | Experimental | Biological: Auto CAR-T, Drug: Cyclophosphamide,Fludarabine, Procedure: LeukapheresisPatients will be treated with Auto CAR-T cells |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Sign the informed consent 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;
- Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
- Age: 1-18 years (including boundary value), both male and female;
- Subjects with Lansky score ≥ 50;
- The results of treatment-related antigens were positive;
Key exclusion criteria (11 listed)
- Severe cardiac insufficiency and left ventricular ejection fraction < 50%;
- He had a history of severe lung function damage;
- Combined with other advanced malignant tumors;
- Severe infection was found and could not be effectively controlled;
- With metabolic diseases (except diabetes mellitus);
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 |
|---|---|---|
| Auto CAR-TBiological: Auto CAR-T | Biological | Auto CAR-T |
| Cyclophosphamide,FludarabineDrug: Cyclophosphamide,Fludarabine | Drug | Auto CAR-T |
| LeukapheresisLeukapheresis | Procedure or surgery | Auto 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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
Time frame: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD)
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
Lian Jiang, MD principal investigator
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis in people with Leukemia and Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. 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 6 inclusion and 11 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 30 Oct 2020. 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.
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 Jianqiang Li, PhD&MD (008615511369555, limmune@gmail.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 30 Oct 2020.