CAR-T cell therapy targeting CD5 and CD7 for T-cell leukemia and lymphoma

This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7/CD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).

This study is testing a new CAR-T cell therapy for young people with tough-to-treat T-cell leukemia and lymphoma to see if it can help them when other treatments haven't worked.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 2 Years to 90 Years
• Sex: All
• Sponsor: Essen Biotech (Academic / other)
• Drugs / interventions: CAR-T, Chimeric antigen receptor, CAR T, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06420076 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Sequential CAR-T Cells specifically targeting CD5 and CD7 in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL). The study aims to address the critical unmet medical need for effective treatments in this patient population, particularly after conventional therapies have failed. Participants will receive CAR-T cell therapy, and the study will monitor for adverse effects, including cytokine storm responses, as well as assess disease status post-treatment. The trial includes patients aged 2 to 60 years who have a significant burden of leukemic cells expressing CD5 and/or CD7.

Who should consider this trial

Good fit: Ideal candidates are patients aged 2-60 years with relapsed or refractory T-ALL or LBL whose leukemic cells express CD5 and/or CD7.

Not a fit: Patients who have declined to consent for treatment or have prior solid organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with limited alternatives for relapsed or refractory T-cell leukemia and lymphoma.

How similar studies have performed: While CAR-T cell therapies have shown success targeting other antigens, this specific approach targeting CD5 and CD7 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Signed written informed consent; Patients volunteer to participate in the clinical trial;
* Diagnosis is mainly based on the World Health Organization (WHO) 2008;
* Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
* Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
* The expected survival period is greater than 12 weeks;
* ECOG score ≤2;
* Age 2-60 years old;
* HGB≥70g/L (can be transfused);
* Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria:

* Patients declining to consent for treatment
* Prior solid organ transplantation
* One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
* History of severe pulmonary dysfunction diseases;
* Severe infection or persistent infection cannot be effectively controlled;
* Severe autoimmune disease or congenital immunodeficiency;
* Active hepatitis;
* Human immunodeficiency virus (HIV) infection;
* Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).

Where this trial is running

Beijing, Beijing Municipality

• District One Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Rhoda M Smith, Phd

Conditions T Cell Lymphoma; T Cell Leukemia; T-cell Acute Lymphoblastic Leukemia; T-Cell Lymphoma of CNS; T Cell Prolymphocytic Leukemia; T Cell Childhood ALL; CAR-T; CD5