Using CD5 CAR-T Cells to treat relapsed T-Acute Lymphoblastic Leukemia

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 effectiveness of CD5 CAR-T cell therapy in patients with relapsed refractory CD5+ T-Acute Lymphoblastic Leukemia (T-ALL). A total of 30 patients diagnosed with this condition will receive the treatment, building on previous studies that have established its safety. The trial aims to gather more data on the effectiveness of this therapy and expand the understanding of its safety profile in a larger patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
* 2\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

  1. No CR after standard chemotherapy;
  2. The first induction reaches CR, but CR ≤ 12 months;
  3. Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

  c.Multiple recurrences.
* 3\. CD5 expression rate was \>90%;
* 4\. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);
* 5\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
* 6\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
* 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
* 8.Estimated life expectancy of minimum of 12 weeks;
* 9.ECOG 0-2;
* 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
* 11\. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1.Patients with the history of epilepsy or other CNS disease;
* 2\. Patients with prolonged QT interval time or severe heart disease;
* 3\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
* 4\. Active infection with no cure;
* 5\. Before using any gene therapy products;
* 6\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:

  1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug);
  2. received within 72 hours of small molecule targeted therapy;
  3. 2 weeks received systemic chemotherapy except (pretreatment);
  4. four weeks received radiotherapy;
* 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8\. Any unsuitable to participate in this trial judged by the investigator;
* 9\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Where it's running

• The first affiliated hospital of medical college of zhejiang university
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: He Huang, MD — First Affiliated Hospital of Zhejiang University
• Study coordinator: He Huang, MD
• Email: hehuangyu@126.com
• Phone: 057187233772

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

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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.