Clinical Study of Anti-CD1a CAR-T in the Treatment of R/R Acute T-lymphoblastic Leukemia/Lymphoblastic Lymphoma

NCT05745181 | Unknown Phase 2

• 1 other identifier: XYFY2022-KL479-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma.

Conditions

Acute T-lymphoblastic Leukemia; Acute T-lymphoblastic Lymphoma

Keywords

anti-CD1a CAR-T; relapsed refractory

Outcome Measures

Primary Outcomes (4)

• Objective response rate

  CR+PR

  From 2 weeks to 1 year.

• Progression-free survival

  The time between treatment and observation of disease progression or death from any cause.

  From 2 weeks to 1 year.

• overall survival

  The time interval between patient infusion of CAR-T and death from any cause or the end of follow-up.

  From 2 weeks to 1 year.

• Event-free survival

  The time from the start of CAR-T infusion to the occurrence of any event.

  From 2 weeks to 1 year.

Secondary Outcomes (3)

• Characterization of the level of CAR T cell expansion in subjects over time

  From 2 weeks to 1 year.

• Duration of CAR T cells in subjects

  From 2 weeks to 1 year.

• Characteristics of lymphocyte reduction in subjects

  From 2 weeks to 1 year.

Study Arms (1)

CAR-T Cell Infusion

EXPERIMENTAL

Peripheral blood mononuclear cells were isolated, amplified and cultured in vitro, pretreated with FC regimen, and Anti-CD1a CAR-T cells were transfused.

Biological: CAR-T Cell Infusion

Interventions

CAR-T Cell Infusion BIOLOGICAL

Peripheral blood mononuclear cells were isolated, amplified and cultured in vitro, pretreated with FC regimen, and Anti-CD1a CAR-T cells were transfused.

CAR-T Cell Infusion

Eligibility Criteria

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

You may qualify if:

• Patients or their legal guardians voluntarily participate and sign the informed consent;
• Male or female patients aged 18-70 years (including 18 and 70 years);
• The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology or flow cytometry, and had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Alternatively, the patient voluntarily chooses to administer antiCD1A-CAR T cells as salvage therapy.
• The following two categories are included:
• (1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:
• There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
• Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
• Patients with high risk factors;
• Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
• \. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
• Renal function: creatinine \< 220 μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss); 9. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3 months. 4. The following two categories are included:
• (1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:

You may not qualify if:

• Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;
• Men or women who have planned to become pregnant within the last 1 year;
• The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;
• Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
• Active hepatitis B/C virus;
• Hiv-infected patients;
• Suffering from a serious autoimmune disease or immunodeficiency disease;
• The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
• The patient had participated in other clinical trials within 6 weeks prior to enrollment;
• Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
• Suffers from mental illness;
• The patient has substance abuse/addiction;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

RECRUITING

Central Study Contacts

Wei Sang, M.D., Ph.D.

CONTACT

13645207648; xyfylbl515@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 27, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)