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

NCT ID: NCT05350787

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2025-08-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

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

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

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

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

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

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

Patients will receive 12×10\^6 cells/kg of ThisCART19A

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: BIOLOGICAL

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

Interventions

ThisCART19A

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);

3. There is no gender limitation, age 18-70(upper limit not included);

4. 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.

5. The expected survival time is ≥12 weeks;

6. ECOG score 0-1;

7. Had good organic function during screening

8. 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

1. Allergic to preconditioning measures.

2. 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.

3. Uncontrollable bacterial, fungal and viral infection during screening.

4. Patients had pulmonary embolism within 3 months prior to enrollment.

5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.

6. Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.

7. 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.

8. 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.

9. 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) .

10. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.

11. 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.

12. Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

President/Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The first hospital affiliated Zhejiang University

Locations

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingming Zhang, Doctor

Role: CONTACT

mingmingzhang@zju.edu.cn

13656674208

Facility Contacts

He Huang, PhD

Role: primary

hehuangyu@126.com

86-13605714822

Mingming Zhang, PhD

Role: backup

mingmingzhang@zju.edu.cn

86-13656674208

Mingming Zhang, Doctor

Role: primary

mingmingzhang@zju.edu.cn

13656674208

Other Identifiers

FT400-004

Identifier Type: -

Identifier Source: org_study_id