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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• District One Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rhoda M Smith, Phd
• Email: clinical-trials@essen-biotech.com
• Phone: +12077706670

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anti-CCR9 CAR T-cell therapy for T‑cell acute lymphoblastic leukaemia and lymphoblastic lymphoma

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• CD7 CAR T therapy for high-risk T-cell cancers

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.