Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL

NCT05350787 | Completed Phase 1

• 1 other identifier: FT400-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

B-ALL

Outcome Measures

Primary Outcomes (2)

• 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.

  28 days

• The incidence of all grade TEAEs and ≥3 grade TEAEs

  Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs

  Up to 2 years after ThisCART19A infusion

Secondary Outcomes (5)

• Objective response rate

  At Month 1, 2, 3

• The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion

  3 months

• Changes in cytokine level after ThisCART19A infusion.

  3 months

• Changes in immune effect cells count after ThisCART19A infusion.

  3 months

• MRD response rate

  24 months

Study Arms (2)

ThisCART19A 3×10^6 cells/kg for dose level 1

EXPERIMENTAL

Patients will receive 3×10\^6 cells/kg of ThisCART19A

Biological: ThisCART19A

ThisCART19A 5×10^6 cells/kg as dose level 2

EXPERIMENTAL

Patients will receive 5×10\^6 cells/kg of ThisCART19A

Biological: ThisCART19A

Interventions

ThisCART19A BIOLOGICAL

ThisCART19A is a new type CAR-T cells therapy for patients with acute B-cell leukemia

ThisCART19A 3×10^6 cells/kg for dose level 1; ThisCART19A 5×10^6 cells/kg as dose level 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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);

You may not qualify if:

• 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) .
• 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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Location

Study Officials

• He Huang, Doctor

  The first hospital affiliated Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President/Proffessor

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 28, 2022
• Study Start: March 18, 2022
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (2)