Treatment of relapsed acute T-lymphoblastic leukemia with anti-CD1a CAR-T therapy

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

This study tests a new CAR-T cell therapy that targets a specific protein to see if it can help people with relapsed acute T-lymphoblastic leukemia feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Drugs / interventions: CAR T, chemotherapy, immunotherapy, CAR-T
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT05745181 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of anti-CD1a CAR-T cell therapy for patients with relapsed or refractory acute T-lymphoblastic leukemia and lymphoblastic lymphoma. The study focuses on patients whose tumors express the CD1a antigen, which is present in approximately 40% of T-ALL cases. Participants will receive CAR-T cell infusions specifically targeting CD1a, aiming to minimize non-tumor toxicity while effectively treating the malignancy. The study will assess both the safety profile and the therapeutic outcomes of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with CD1a+ acute T-lymphoblastic leukemia or lymphoblastic lymphoma who have exhausted standard treatment options.

Not a fit: Patients with CD1a-negative tumors or those who are not in the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, targeted therapy option for patients with limited treatment alternatives for relapsed acute T-lymphoblastic leukemia.

How similar studies have performed: While CAR-T therapies have shown promise in treating various hematological malignancies, this specific approach targeting CD1a is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

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

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.
4. The following two categories are included:

(1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:

1. There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
2. Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
3. Patients with high risk factors;
4. 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:

1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
2. Renal function: creatinine \< 220 μmol/L;
3. Lung function: indoor oxygen saturation ≥95%;
4. 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:

1. There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
2. Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
3. Patients with high risk factors;
4. 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:

1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
2. Renal function: creatinine \< 220 μmol/L;
3. Lung function: indoor oxygen saturation ≥95%;
4. 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.

Exclusion Criteria:

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

Where this trial is running

Xuzhou, Jiangsu

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wei Sang, M.D., Ph.D.

Conditions Acute T-lymphoblastic Leukemia; Acute T-lymphoblastic Lymphoma; anti-CD1a CAR-T; relapsed refractory