CD5 CAR-T therapy for treating relapsed T-cell leukemia

A Phase I Study of CD5 CAR-T for Refractory/Relapsed CD5+ T-ALL Patients

This study is testing a new type of CAR-T therapy for people with hard-to-treat T-cell leukemia to see if it can help them when other options have failed.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Drugs / interventions: CAR-T, CAR T, chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05596266 on ClinicalTrials.gov

What this trial studies

This phase I interventional study evaluates the safety and tolerability of CD5 CAR-T cells in patients with refractory or relapsed CD5+ T-cell acute lymphoblastic leukemia (T-ALL) who lack curative treatment options. The study involves a single-arm, open-label design where eligible patients will receive an infusion of CAR T-cells specifically targeting CD5. The aim is to explore the potential efficacy of this innovative therapy in a population with limited treatment alternatives and poor prognosis.

Who should consider this trial

Good fit: Ideal candidates for this study are children and young adults aged 1 to 18 years with refractory or relapsed CD5-positive T-ALL.

Not a fit: Patients with non-CD5-positive tumors or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed T-ALL, potentially improving their outcomes.

How similar studies have performed: While CAR-T therapies have shown success in other hematological malignancies, the specific application of CD5 CAR-T therapy in T-ALL is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. 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;
3. Aged 1 to 18 years (including 18 years old);
4. Eastern Cooperative Oncology Group (ECOG) score 0-2;
5. Life expectancy greater than 12 weeks;
6. Oxygen saturation of blood\>90%;
7. Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 × upper limit of normal;
8. Informed consent explained to, understood by and signed by patient/guardian.

Exclusion Criteria:

1. Intracranial hypertension or brain consciousness disorder;
2. Has an active GvHD;
3. Has a history of severe pulmonary function damaging;
4. With other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
5. Severe or persistent infection that cannot be effectively controlled；
6. Presence of severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
8. Patients with HIV infection or syphilis infection;
9. Has a history of serious allergies to biological products (including antibiotics);
10. Clinically significant viral infection or uncontrolled viral reactivation of EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV (human herpesvirus)-6;
11. 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;
12. Received allogeneic hematopoietic stem cell transplantation within 6 months;
13. Being pregnant and lactating or having pregnancy within 12 months;
14. Any situations that the researchers believe will increase the risk for the subject or affect the results of the study.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhiguo Chen, PhD — Xuanwu Hospital, Beijing
• Study coordinator: Zhiguo Chen, PhD

Conditions T-cell Acute Lymphoblastic Leukemia; CD5 CAR-T; T-ALL