T-Acute Lymphoblastic LeukemiaPhase 1NCT05127135
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
A Phase 1 study testing ThisCART7 cells in people with T-Acute Lymphoblastic Leukemia and T-cell Non-Hodgkin Lymphoma, run by Fundamenta Therapeutics, Ltd. at 2 sites in China.
Trial summary
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma
- What is being tested?
- ThisCART7 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jan 2020to 24 Dec 2023
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
- No alternative treatment options deemed by investigator;
- Measurable or detectble disease at time of enrollment;
- Age 18-70 years old, no gender and race limited;
- Eastern cooperative oncology group (ECOG) performance status of ≤2;
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
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- Estimated life expectancy > 12 weeks deemed by investigator;
- Serum creatinine ≤ 1.5 upper limit of normal (ULN);
- Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
- Signed informed consent form (ICF).
Who cannot join
- Women in pregnancy or lactation;
- Uncontrolled infection;
- Active hepatitis B virus or hepatitis C virus infection;
- Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
- Prior treatment with an allogeneic stem cell transplant within 100 days;
- Grade 2-4 Active graft versus host disease;
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- History of HIV infection;
- With central nervous system involvement;
- Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui
Xingbing Wang, +86-18056075256, wangxingbing@ustc.edu.cn
- Recruiting
Fundamenta Therapeutice Co.,Ltd
Suzhou, Jiangsu
Jun Li, +8618662604088, jli@ctigen.com
Ling He, +8618626100886, lhe@ctigen.com
About this study
Official title: A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
Read the detailed description
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
- Conditions
- T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma
- Being tested
- ThisCART7 cells
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART7 cellsBiological
0.5-6 x 10^6 CAR T cells per kg body weight
| Study group | Role | What they receive |
|---|---|---|
| ThisCART7 cells injections | Experimental | In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies. Receives: Biological: ThisCART7 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related grade≥3Adverse Events or SAE
Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: within 4 weeks after infusion
Secondary outcomes (1)
Objective Response Rate
Description:
For T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ;
For lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria.
Measured: 4 to 6 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start22 Jan 2020
- Primary completion24 Jan 2023 (estimated)
- Study completion24 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Acute Lymphoblastic 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundamenta Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Responsible party
- Sponsor
- Investigators
- Wang Xingbing, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127135
- Sponsor's protocol ID
- ThisCART7
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
- ClinicalTrials.gov ID
- NCT05127135
- Acronym / sponsor ID
- ThisCART7
- Conditions
- T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundamenta Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 24 Jan 2023 (estimated)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 19 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.
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
Detailed description
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThisCART7 cells injections | Experimental | Biological: ThisCART7 cellsIn this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
- No alternative treatment options deemed by investigator;
- Measurable or detectble disease at time of enrollment;
- Age 18-70 years old, no gender and race limited;
- Eastern cooperative oncology group (ECOG) performance status of ≤2;
Key exclusion criteria (9 listed)
- Women in pregnancy or lactation;
- Uncontrolled infection;
- Active hepatitis B virus or hepatitis C virus infection;
- Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
- Prior treatment with an allogeneic stem cell transplant within 100 days;
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 |
|---|---|---|
| ThisCART7 cells0.5-6 x 10^6 CAR T cells per kg body weight | Biological | ThisCART7 cells injections |
Primary outcome
Incidence of Treatment-related grade≥3Adverse Events or SAE
Time frame: within 4 weeks after infusion
Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
1 secondary outcome
Objective Response Rate
Time frame: 4 to 6 weeks after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- 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.
Wang Xingbing principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ThisCART7 cells in people with T-Acute Lymphoblastic Leukemia and T-cell Non-Hodgkin Lymphoma, run by Fundamenta Therapeutics, 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 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 19 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 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.
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 Li Jun, Ph.D (+86-18662604088, jli@ctigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related grade≥3Adverse Events or SAE (time frame: within 4 weeks after 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 19 Nov 2021.