Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD+ B-ALL

NCT05350852 | Unknown Phase 1

• 1 other identifier: FT400-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

  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

  Up to 2 years after ThisCART19A infusion

Secondary Outcomes (5)

• Relapse-Free Survival

  24 months

• MRD 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

Study Arms (3)

ThisCART19A 5×10^6 cells/kg for dose level 1

EXPERIMENTAL

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

Biological: ThisCART19A

ThisCART19A 8×10^6 cells/kg for dose level 2

EXPERIMENTAL

Patients will receive 8×10\^6 cells/kg of ThisCART19A

Biological: ThisCART19A

ThisCART19A 12×10^6 cells/kg for dose level 3

EXPERIMENTAL

Patients will receive 12×10\^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 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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 18-65 (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;
• 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).

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.
• \< 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) .
• 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 (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

Study Officials

• He Huang, Doctor

  The first hospital affiliated Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingming z Zhang, Doctor

CONTACT

13656674208; mingmingzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• 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: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CN (1)