B-ALLPhase 1NCT05350852
Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD+ B-ALL
A Phase 1 study testing ThisCART19A in people with B-ALL, run by Zhejiang University at 1 site in China.
Trial summary
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- B-ALL
- What is being tested?
- ThisCART19A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2022to 30 Apr 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects or legal representatives must sign a voluntary letter of consent approved by the IRB in person prior to the commencement of any screening procedure;
- Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
- There is no gender limitation, age 18-65 (upper limit not included);
- Disease status ≥CR2 with bone marrow flow cytometry MRD≥0.1%.
- Patients with Ph+ R/R ALL who failed after 2-line TKI treatment, were intolerant to TKI treatment or were not suitable for TKI treatment;
- The expected survival time is ≥12 weeks;
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- ECOG score 0-1;
- Had good organic function during screening
- CD19 was still expressed on leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry, results within one month prior to informed consent are acceptable (after the last treatment).
Who cannot join
- Allergic to preconditioning measures.
- Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma,basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
- Uncontrollable bacterial, fungal and viral infection during screening.
- Patients had pulmonary embolism within 3 months prior to enrollment.
- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
- Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
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- < 100 days after hematopoietic stem cell transplantation.
- Active HBV or HCV or HIV or Syphilis infection. HBV-DNA < 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenufovir, etc, and supervisory the relative indication during the treatment.
- Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
- Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
- Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
- Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, Doctor, 86-13605714822, hehuangyu@126.com
About this study
Official title: To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD Positive Acute B-cell Leukemia
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL
- Conditions
- B-ALL
- Being tested
- ThisCART19A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ABiological
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19A 5×10^6 cells/kg for dose level 1 | Experimental | Patients will receive 5×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
| ThisCART19A 8×10^6 cells/kg for dose level 2 | Experimental | Patients will receive 8×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
| ThisCART19A 12×10^6 cells/kg for dose level 3 | Experimental | Patients will receive 12×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Measured: Up to 28 days after ThisCART19A infusion
The incidence of all grade TEAEs and ≥3 grade TEAEs
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Measured: Up to 2 years after ThisCART19A infusion
Secondary outcomes (5)
Relapse-Free Survival
Defined as the time from the infusion of ThisCART19A cells to the occurrence of hematologic relapse or death from any cause.Hematologic recurrence was defined as ≥5% of bone marrow lymphoblasts or extramedullary recurrence after CR or CRi
Measured: 24 months
MRD response rate
Percentage of participants with minimal residual disease (MRD) response in patients with CR (complete response) and CRi (CR with incomplete blood count recovery) ; MRD Response is defined as leukemic cells in bone marrow <0.01% by flow cytometry (sensitivity at least 0.001%)
Measured: At Month 1, 2, 3
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR
Measured: 3 months
Changes in cytokine level after ThisCART19A infusion.
Calculate the change of cytokine level in peripheral blood by flow cytometry after ThisCART19A infusion. Cytokines include IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、IL-12、IL-17、TNF-α、IFN-γ、TGF-β.
Measured: 3 months
Changes in immune effect cells count after ThisCART19A infusion.
Calculate the change of immune effect cells count in peripheral blood by flow cytometry after ThisCART19A infusion. Immune effect cells include T cell, B cell, NK cell.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start18 Mar 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-ALLStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, Doctor, Principal investigator, The first hospital affiliated Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350852
- Sponsor's protocol ID
- FT400-005
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD Positive Acute B-cell Leukemia
- ClinicalTrials.gov ID
- NCT05350852
- Acronym / sponsor ID
- FT400-005
- Conditions
- B-ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Apr 2022 (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 an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ThisCART19A 5×10^6 cells/kg for dose level 1 | Experimental | Biological: ThisCART19APatients will receive 5×10^6 cells/kg of ThisCART19A |
| ThisCART19A 8×10^6 cells/kg for dose level 2 | Experimental | Biological: ThisCART19APatients will receive 8×10^6 cells/kg of ThisCART19A |
| ThisCART19A 12×10^6 cells/kg for dose level 3 | Experimental | Biological: ThisCART19APatients will receive 12×10^6 cells/kg of ThisCART19A |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
Key exclusion criteria (13 listed)
- Allergic to preconditioning measures.
- Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma,basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
- Uncontrollable bacterial, fungal and viral infection during screening.
- Patients had pulmonary embolism within 3 months prior to enrollment.
- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
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 |
|---|---|---|
| ThisCART19AThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia | Biological | ThisCART19A 12×10^6 cells/kg for dose level 3, ThisCART19A 5×10^6 cells/kg for dose level 1, ThisCART19A 8×10^6 cells/kg for dose level 2 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days after ThisCART19A infusion
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
The incidence of all grade TEAEs and ≥3 grade TEAEs
Time frame: Up to 2 years after ThisCART19A infusion
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
5 secondary outcomes
Relapse-Free Survival
Time frame: 24 months
MRD response rate
Time frame: At Month 1, 2, 3
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Time frame: 3 months
Changes in cytokine level after ThisCART19A infusion.
Time frame: 3 months
Changes in immune effect cells count after ThisCART19A infusion.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
He Huang, Doctor principal investigator
The first hospital affiliated Zhejiang 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 ThisCART19A in people with B-ALL, run by Zhejiang University 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 9 inclusion and 13 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 28 Apr 2022. 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 Mingming z Zhang, Doctor (13656674208, mingmingzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 28 days after ThisCART19A 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 28 Apr 2022.