B-cell MalignancyPhase 1NCT05106907
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
A Phase 1 study testing ThisCART19 cells in people with B-cell Malignancy, run by Fundamenta Therapeutics, Ltd. at 1 site in China.
Trial summary
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Malignancy
- What is being tested?
- ThisCART19 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 24 Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, no gender and race limited;
- Estimated life expectancy > 12 weeks deemed by investigator；
- CD19 were positive by histopathology and/or cytology diagnosis；
- Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
- Relevant indicators for disease or assessment within 4 weeks after the last treatment;
- Quality of Life Score (KPS) >50%；
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- Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
- No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
- Unsuitable conditions for stem cell transplantation;
- Signed informed consent form (ICF).
Who cannot join
- Women in pregnancy or lactation;
- In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
- The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
- Abnormal vital signs and failure to cooperate with examination;
- Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
- Highly allergic constitution or history of severe allergy;
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- Patients with systemic infection or severe local infection requiring anti-infection treatment;
- Patients with severe autoimmune diseases;
- Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
zhenyu li, 15950688971, lizhenyumd@163.com
About this study
Official title: An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Read the detailed description
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
- Conditions
- B-cell Malignancy
- Being tested
- ThisCART19 cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19 cellsBiological
0.2-60 x 10^6 CAR T cells per kg body weight
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19 cells injections | Experimental | In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies. Receives: Biological: ThisCART19 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse events
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Measured: 90 days post infusion
Secondary outcomes (4)
Overall Remission Rate (ORR)
Anti-tumor efficacy by 2014 Lugano criteria
Measured: up to 90 days
Progression free survival time
The interval between administration and disease progression or death
Measured: 3 years
Overall survival time
The interval between administration and death caused by any reason
Measured: 3 years
Event-free survival (EFS)
EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start25 Oct 2021
- Primary completion24 Oct 2023 (estimated)
- Study completion24 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundamenta Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Zhengyu Li, Ph.D, Study chair, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106907
- Sponsor's protocol ID
- FT400-002
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 4 Nov 2021
- 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)
- ClinicalTrials.gov ID
- NCT05106907
- Acronym / sponsor ID
- FT400-002
- Conditions
- B-cell Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundamenta Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 24 Oct 2023 (estimated)
- Study completion
- 24 Oct 2024 (estimated)
- First posted
- 4 Nov 2021 (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.
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Detailed description
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThisCART19 cells injections | Experimental | Biological: ThisCART19 cellsIn this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years old, no gender and race limited;
- Estimated life expectancy > 12 weeks deemed by investigator；
- CD19 were positive by histopathology and/or cytology diagnosis；
- Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
- Relevant indicators for disease or assessment within 4 weeks after the last treatment;
Key exclusion criteria (9 listed)
- Women in pregnancy or lactation;
- In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
- The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
- Abnormal vital signs and failure to cooperate with examination;
- Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
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 |
|---|---|---|
| ThisCART19 cells0.2-60 x 10^6 CAR T cells per kg body weight | Biological | ThisCART19 cells injections |
Primary outcome
Treatment related adverse events
Time frame: 90 days post infusion
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
4 secondary outcomes
Overall Remission Rate (ORR)
Time frame: up to 90 days
Progression free survival time
Time frame: 3 years
Overall survival time
Time frame: 3 years
Event-free survival (EFS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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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.
Zhengyu Li, Ph.D study chair
The Affiliated Hospital of Xuzhou Medical 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 ThisCART19 cells in people with B-cell Malignancy, run by Fundamenta Therapeutics, 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 10 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 4 Nov 2021. 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 Jun Li, Ph.D (18662604088, jli@ctigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related adverse events (time frame: 90 days post infusion). 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 4 Nov 2021.