CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

Capital Medical University

Status and phase

Enrolling

Phase 1

Conditions

T-cell Acute Lymphoblastic Leukemia

Treatments

Biological: CD5 CAR-T

Study type

Interventional

Funder types

Other

Identifiers

NCT05596266

202001

Details and patient eligibility

About

This is a phase I, interventional, single arm, open label, clinical study to evaluate the safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who have no available curative treatment options.

Full description

T-acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive infusion of CAR T-cells targeting CD5 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ relapsed or refractory acute leukemia.

Enrollment

20 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patients whose tumor burden >5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible;
CD5-positive tumor (≥70% CD5 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors burden >5%,or MRD+， or new extramedullary lesions reappeared;
Aged 1 to 18 years (including 18 years old);
Eastern Cooperative Oncology Group (ECOG) score 0-2;
Life expectancy greater than 12 weeks;
Oxygen saturation of blood>90%;
Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 × upper limit of normal;
Informed consent explained to, understood by and signed by patient/guardian.

Exclusion criteria

Intracranial hypertension or brain consciousness disorder;
Has an active GvHD;
Has a history of severe pulmonary function damaging;
With other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
Severe or persistent infection that cannot be effectively controlled；
Presence of severe autoimmune diseases or immunodeficiency disease;
Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
Patients with HIV infection or syphilis infection;
Has a history of serious allergies to biological products (including antibiotics);
Clinically significant viral infection or uncontrolled viral reactivation of EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV (human herpesvirus)-6;
Presence of any symptomatic CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
Received allogeneic hematopoietic stem cell transplantation within 6 months;
Being pregnant and lactating or having pregnancy within 12 months;
Any situations that the researchers believe will increase the risk for the subject or affect the results of the study.