Hodgkin's LymphomaNCT04665063
A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma
A study testing Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis in people with Hodgkin's Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, non-randomized, single-arm, open clinical trial. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Hodgkin's Lymphoma
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2020to 21 Oct 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;
- Hodgkin lymphoma patients who are judged to be relapsed/refractory by clinical diagnosis, relapse or refractory are defined as:
- Primary resistance to standard treatment regimens;
- Or PD occurs after standard treatment with at least second-line standard treatment plan;
- Or the last treatment effect is SD and the duration does not exceed 6 months;
- Or after anti-PD-1 monoclonal antibody treatment is ineffective or relapses;
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- Patients who have PD after autologous hematopoietic stem cell transplantation or confirmed recurrence by biopsy within 12 months, or patients who undergo salvage treatment after autologous hematopoietic stem cell transplantation have no remission or relapse after treatment.
- According to RECIST version 1.1 , there should be at least one measurable tumor;
- Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0~2;
- 14 years old ≤ age ≤ 75 years old, both male and female;
- Immunohistochemistry or flow cytometry detects tumor cells as CD30 or CD19/CD22/CD79 positive;
- The estimated survival period from the date of signing the informed consent form is greater than 3 months;
- Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 109/L, absolute neutrophil count (ANC) ≥1.0 × 109/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor;
- The main organ functions need to meet the following conditions: serum creatinine ≤1.5 ULN, AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum lung function reserve (dyspnea is not higher than level 1 and blood oxygen saturation is greater than 92% under indoor conditions).
Who cannot join
- Severe cardiac insufficiency, left ventricular ejection fraction <50%;
- There is a history of severe lung dysfunction diseases;
- The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
- Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
- Combined metabolic diseases (except diabetes);
- Combined with severe autoimmune disease or innate immune deficiency;
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- Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, 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 C co-infection;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- A history of severe allergies to biological products (including antibiotics);
- Participate in any other clinical drug trials at the same time within one month;
- There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Department, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Lihong Liu, PhD & MD, +8613831177920, limmune@gmail.com
Baoen Shan, PhD & MD
About this study
This study is a multi-center, non-randomized, single-arm, open clinical trial.
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.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Auto CAR-T, Cyclophosphamide,Fludarabine, Leukapheresis
- Medical subject headings
- Hodgkin Disease
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 one month after CAR-T infusion
Efficacy: Remission Rate
Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and and unresponsive (NR)
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (2)
Efficacy:duration of response (DOR)
duration of response (DOR)
Measured: 24 months after CAR-T infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start22 Oct 2020
- Primary completion21 Oct 2023 (estimated)
- Study completion21 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Hebei Medical University Fourth Hospital
- Responsible party
- Sponsor
- Investigators
- Baoen Shan, PhD & MD, Principal investigator, Hebei Medical University Fourth HospitalLihong Liu, PhD & MD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665063
- Sponsor's protocol ID
- 2020103
- Status last verified
- Oct 2020
- First submitted
- 7 Dec 2020
- Last updated
- 29 Dec 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 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04665063
- Acronym / sponsor ID
- 2020103
- Conditions
- Hodgkin's Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 21 Oct 2023 (estimated)
- Study completion
- 21 Oct 2025 (estimated)
- First posted
- 11 Dec 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 study is a multi-center, non-randomized, single-arm, open clinical trial.
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
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;
- Hodgkin lymphoma patients who are judged to be relapsed/refractory by clinical diagnosis, relapse or refractory are defined as:
- According to RECIST version 1.1 , there should be at least one measurable tumor;
- Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0~2;
- 14 years old ≤ age ≤ 75 years old, both male and female;
Key exclusion criteria (11 listed)
- Severe cardiac insufficiency, left ventricular ejection fraction <50%;
- There is a history of severe lung dysfunction diseases;
- The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
- Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
- Combined metabolic diseases (except diabetes);
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 one month after CAR-T 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 remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and and unresponsive (NR)
2 secondary outcomes
Efficacy:duration of response (DOR)
Time frame: 24 months after CAR-T infusion
Efficacy: progression-free survival (PFS)
Time frame: 24 months after CAR-T infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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.
Baoen Shan, PhD & MD principal investigator
Hebei Medical University Fourth Hospital
Lihong Liu, PhD & 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 Hodgkin's 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 14 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 29 Dec 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 one month after CAR-T 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 Dec 2020.