B-ALLPhase 1NCT05350787
Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL
A Phase 1 study testing ThisCART19A in people with B-ALL, run by Zhejiang University at 2 sites in China.
Trial summary
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with relapsed and refractory acute B-cell leukemia Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 18 Mar 2022to 21 May 2025
- 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
- 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 18-70(upper limit not included);
- Consistent with the diagnosis of recurrent refractory B-ALL. Recurrence： was defined as the recurrence of lymphoblasts（≥5%） in peripheral blood or bone marrow or extramedullary diseasefor patients who had acquired CR ; Refractory ：was defined as failure to CR or CRi at the end of induction therapy (generally referred to 4-week regimen or Hyper-CVAD regimen);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 following factors can coexist:
- Failure to prepare autologous CAR-T (definition: too few autologous lymphocytes [200/ML] or cannot meet the release standard); B) Experienced treatment with auto car-T/berintoomumab/ CD22 antibody conjugation drugs; C) ≥100 days after hematopoietic stem cell transplantation; D) high-risk patients (High risk was defined as a high white blood cell count ≥30×109/L at diagnosis or with poor cytogenetic prognosis);
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- Hypodiploid (<44 chromosomes);
- KMT2A rearrangement: t (4;11) or otherwise;
- t (v;q32)/IgH;
- t (9;22) (q34;q11.2) or BCR-ABL1;
- Complex karyotype (≥5 chromosomal abnormalities);
- BCR-ABL1-like (Ph-like) ALL;
- JAK-STAT (CRLF2r, EPORr, JAK1/2/3r, TYK2r, mutations of SH2B3, IL7r, Jak1/2/3 );
- ABL class( rearrangement of ABL1, ABL2, PDGFRA, PDGFRB, FGFR);
- Other (NTRKr, FLT3r, LYNr, PTK2Br);
- Intrachromosomal amplification of chromosome 21 (IAMP21-ALL);
- t (17;19) : TCF3-HLF fusion ;
- Alterations of IKZF1; E) Extramedullary lesions.
- The expected survival time is ≥12 weeks;
- ECOG score 0-1;
- Had good organic function during screening
- CD19 was still expressed in leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry within one month prior to informed consent (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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- 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
2 sites in 1 country.
China2 sites
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310003
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang
About this study
Official title: To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Relapsed and Refractory Acute B-cell Leukemia
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with relapsed and refractory acute B-cell leukemia
- 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 3×10^6 cells/kg for dose level 1 | Experimental | Patients will receive 3×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
| ThisCART19A 5×10^6 cells/kg as dose level 2 | Experimental | Patients will receive 5×10^6 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 limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Measured: 28 days
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)
Objective response rate
Objective response rate (ORR = CR + CRi) of ThisCART19A within 3 months after administration
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
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: 24 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 completion21 May 2025
- Study completion21 May 2025
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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- NCT05350787
- Sponsor's protocol ID
- FT400-004
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2022
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. 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 Relapsed and Refractory Acute B-cell Leukemia
- ClinicalTrials.gov ID
- NCT05350787
- Acronym / sponsor ID
- FT400-004
- Conditions
- B-ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- 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 relapsed and refractory acute B-cell leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ThisCART19A 3×10^6 cells/kg for dose level 1 | Experimental | Biological: ThisCART19APatients will receive 3×10^6 cells/kg of ThisCART19A |
| ThisCART19A 5×10^6 cells/kg as dose level 2 | Experimental | Biological: ThisCART19APatients will receive 5×10^6 cells/kg of ThisCART19A |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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 18-70(upper limit not included);
- Consistent with the diagnosis of recurrent refractory B-ALL. Recurrence： was defined as the recurrence of lymphoblasts（≥5%） in peripheral blood or bone marrow or extramedullary diseasefor patients who had acquired CR ; Refractory ：was defined as failure to CR or CRi at the end of induction therapy (generally referred to 4-week regimen or Hyper-CVAD regimen);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;
Key exclusion criteria (12 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 3×10^6 cells/kg for dose level 1, ThisCART19A 5×10^6 cells/kg as dose level 2 |
Primary outcome
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
Time frame: 28 days
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
Objective 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
MRD response rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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
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 ThisCART19A in people with B-ALL, run by Zhejiang University 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 22 inclusion and 12 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: finished, as of the sponsor's last update on 17 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level (time frame: 28 days). 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 17 Feb 2026.