- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350787
Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL
To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Relapsed and Refractory Acute B-cell Leukemia
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Mingming Zhang, Doctor
- Phone Number: 13656674208
- Email: mingmingzhang@zju.edu.cn
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Hospital of Zhejiang Medical Colleage Zhejiang University
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Hangzhou, Zhejiang, China
- Recruiting
- The first affiliated hospital of medical college of zhejiang university
-
Contact:
- Mingming Zhang, Doctor
- Phone Number: 13656674208
- Email: mingmingzhang@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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);
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:
A) 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);
- 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).
Exclusion Criteria:
- 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.
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ThisCART19A 5×10^6 cells/kg for dose level 1
Patients will receive 5×10^6 cells/kg of ThisCART19A
|
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
|
Experimental: ThisCART19A 8×10^6 cells/kg as dose level 2
Patients will receive 8×10^6 cells/kg of ThisCART19A
|
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
|
Experimental: ThisCART19A 12×10^6 cells/kg as dose level 3
Patients will receive 12×10^6 cells/kg of ThisCART19A
|
ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to 2 years after ThisCART19A infusion
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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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Time Frame: 3 months
|
Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR
|
3 months
|
Changes in cytokine level after ThisCART19A infusion.
Time Frame: 3 months
|
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.
|
3 months
|
Changes in immune effect cells count after ThisCART19A infusion.
Time Frame: 3 months
|
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.
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3 months
|
Objective response rate
Time Frame: At Month 1, 2, 3
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Objective response rate (ORR = CR + CRi) of ThisCART19A within 3 months after administration
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At Month 1, 2, 3
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MRD response rate
Time Frame: 24 months
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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%)
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: He Huang, Doctor, The first hospital affiliated Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FT400-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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