B Cell MalignancyPhase 1NCT04384393
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies
A Phase 1 study testing ThisCART19 cells in people with B Cell Malignancy, run by Fundamenta Therapeutics, Ltd. at 2 sites in China.
Trial summary
This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies. Read more about this study
- Who is it for?
- Ages 3 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
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 9 May 2020to 24 Oct 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
- Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
- No alternative treatment options deemed by investigator.
- Measurable or detectble disease at time of enrollment.
- Eastern cooperative oncology group (ECOG) performance status of ≤2.
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
- Estimated life expectancy > 12 weeks deemed by investigator.
Show all 9Show fewer
- Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN).
- Informed consent explained to, understood by and signed by patient/guardian.
Who cannot join
- Pregnant or lactating women
- Uncontrolled infection
- Active hepatitis B virus or hepatitis C virus infection.
- Patients who need steroids to control disease.
- Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
- Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
Show all 9Show fewer
- History of Human Immunodeficiency Virus (HIV) infection.
- Patients with active central nervous system (CNS) involvement by malignancy.
- Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre.
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 Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
Read the detailed description
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10^6 cells per kg body weight.
- 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.
Incidence of Dose Limiting Toxicities
To assess adverse events as dose limiting toxicities as defined by the protocol.
Measured: From infusion to Day 28
Complete Remission
Proportion of patients in whom with morphologic complete remission (CR)
Measured: At Day 28 after ThisCART19 infusion
TRM: Treatment Related Mortality
The mortality related with ThisCART19 infusion.
Measured: Up to 2 years
Secondary outcomes (4)
Objective Response Rate
For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).
Measured: Up to 1 year
Duration of Response
Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.
Measured: Up to 1 year
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: From inclusion up to 1 year
Overall Survival Rate of 2 Years
The rate of patients whom alive at year 2
Measured: At year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start9 May 2020
- Primary completion10 Nov 2022 (estimated)
- Study completion24 Oct 2023 (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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundamenta Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Xingbing Wang, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384393
- Sponsor's protocol ID
- ThisCART19
- Status last verified
- Dec 2021
- First submitted
- 6 May 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. 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 Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
- ClinicalTrials.gov ID
- NCT04384393
- Acronym / sponsor ID
- ThisCART19
- Conditions
- B Cell Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundamenta Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Study start
- 9 May 2020 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 24 Oct 2023 (estimated)
- First posted
- 12 May 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 a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
Detailed description
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 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 |
|---|---|---|
| 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
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
- No alternative treatment options deemed by investigator.
- Measurable or detectble disease at time of enrollment.
- Eastern cooperative oncology group (ECOG) performance status of ≤2.
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
Key exclusion criteria (9 listed)
- Pregnant or lactating women
- Uncontrolled infection
- Active hepatitis B virus or hepatitis C virus infection.
- Patients who need steroids to control disease.
- Patients who accepted autologous stem-cell transplantation (ASCT) 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 |
|---|---|---|
| ThisCART19 cells0.2-60 x 10^6 CAR T cells per kg body weight. | Biological | ThisCART19 cells injections |
Primary outcome
Incidence of Dose Limiting Toxicities
Time frame: From infusion to Day 28
To assess adverse events as dose limiting toxicities as defined by the protocol.
Complete Remission
Time frame: At Day 28 after ThisCART19 infusion
Proportion of patients in whom with morphologic complete remission (CR)
TRM: Treatment Related Mortality
Time frame: Up to 2 years
The mortality related with ThisCART19 infusion.
4 secondary outcomes
Objective Response Rate
Time frame: Up to 1 year
Duration of Response
Time frame: Up to 1 year
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: From inclusion up to 1 year
Overall Survival Rate of 2 Years
Time frame: At year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for B Cell Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Xingbing Wang 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 ThisCART19 cells in people with B Cell Malignancy, 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 9 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 11 Jan 2022. 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 Jun Li, 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 Dose Limiting Toxicities (time frame: From infusion to Day 28). The study lists 3 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 11 Jan 2022.