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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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⁃ 1\. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18-70 years (including 18 and 70 years); 3. 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. Inclusion criteria

• 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.

⁃ 6\. 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:

• 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.

⁃ 6\. 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.

Locations
Other Locations
China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Contact Information
Primary
Wei Sang, M.D., Ph.D.
xyfylbl515@xzhmu.edu.cn
13645207648
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 20
Treatments
Experimental: CAR-T Cell Infusion
Peripheral blood mononuclear cells were isolated, amplified and cultured in vitro, pretreated with FC regimen, and Anti-CD1a CAR-T cells were transfused.
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Hospital of Xuzhou Medical University

This content was sourced from clinicaltrials.gov

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