B-cell Non Hodgkin LymphomaEarly Phase 1NCT04191941
Treatment of Hematological Malignancy With Novel CAR-T Cells.
A Early Phase 1 study testing Novel CAR-T in people with B-cell Non Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Timmune Biotech Inc. at 1 site in China.
Trial summary
This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Multiple Myeloma
- What is being tested?
- Novel CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2021
- Phase
- Early 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
- All subjects must be able to comply with all the scheduled procedures in the study;
- Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
- Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
- At least one clear indicator for hematological malignancy monitoring;
- Aged <70 years;
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- Expected survival ≥12 weeks;
- Eastern cooperative oncology group (ECOG) performance status of≤3;
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
- All other treatment induced adverse events must have been resolved to
- ≤grade 1;
- Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
Who cannot join
- Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
- Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
- Lactating women or women of childbearing age who plan to conceive during the investigational time period;
- Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
- Known history of infection with HIV;
- Subjects need systematic usage of corticosteroid;
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- Subjects need systematic usage of immunosuppressive drug;
- Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
- Other reasons the investigator consider the patient may not be suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Ming Zhou, +86 0731 83928147, zhouming_0321@163.com
About this study
Official title: Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.
This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
Read the detailed description
The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment，as well as stimulating innate T/NK cell activation and expansion.
- Being tested
- Novel CAR-T
- Keywords
- CD19-TriCAR-T, 1922-TriCAR-T, BCMA-TriCAR-T
- Medical subject headings
- Lymphoma, B-Cell, Burkitt Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel CAR-TBiological
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Novel CAR-T | Experimental | Novel CAR-T cells will be administered intravenously Receives: Biological: Novel CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Measured: 3 months
Secondary outcomes (5)
Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
Measured: 3 months
Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)
Partial response rate per the revised International Working Group (IWG) Response Criteria
Measured: 3 months
Duration of Response (The time from response to relapse or progression)
The time from response to relapse or progression
Measured: 24 months
Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)
The time from the first day of treatment to the date on which disease progresses
Measured: 24 months
Overall Survival (The number of patient alive, with or without signs of cancer)
The number of patient alive, with or without signs of cancer
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Sep 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Novel CAR-T Cell Therapy
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Timmune Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Ming Zhou, Principal investigator, Hunan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191941
- Sponsor's protocol ID
- 2019-24.1
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.
- ClinicalTrials.gov ID
- NCT04191941
- Acronym / sponsor ID
- 2019-24.1
- Keywords
- CD19-TriCAR-T, 1922-TriCAR-T, BCMA-TriCAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Timmune Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Dec 2019 (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 single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
Detailed description
The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment，as well as stimulating innate T/NK cell activation and expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Novel CAR-T Cell Therapy
| Arm | Type | Receives |
|---|---|---|
| Novel CAR-T | Experimental | Biological: Novel CAR-TNovel CAR-T cells will be administered intravenously |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
- All subjects must be able to comply with all the scheduled procedures in the study;
- Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
- Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
- At least one clear indicator for hematological malignancy monitoring;
Key exclusion criteria (9 listed)
- Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
- Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
- Lactating women or women of childbearing age who plan to conceive during the investigational time period;
- Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
- Known history of infection with HIV;
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 |
|---|---|---|
| Novel CAR-TA conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells | Biological | Novel CAR-T |
Primary outcome
safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
Time frame: 3 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
5 secondary outcomes
Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
Time frame: 3 months
Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)
Time frame: 3 months
Duration of Response (The time from response to relapse or progression)
Time frame: 24 months
Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)
Time frame: 24 months
Overall Survival (The number of patient alive, with or without signs of cancer)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Ming Zhou principal investigator
Hunan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Novel CAR-T in people with B-cell Non Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Timmune Biotech Inc. 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 12 inclusion and 9 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 10 Dec 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ming Zhou (+86 0731 83928147, zhouming_0321@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) (time frame: 3 months). 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 10 Dec 2019.