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

A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

This study is testing a new type of CAR-T cell therapy to see if it can help people with relapsed T-Acute Lymphoblastic Leukemia feel better and improve their chances of recovery.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, CAR-T
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06633354 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with relapsed refractory CD5+ T-ALL who have not responded to standard treatments.

Not a fit: Patients with CD5-negative T-ALL or those who are not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat relapsed T-ALL.

How similar studies have performed: While this approach is based on established safety data, the specific application of CD5 CAR-T cells in T-ALL is still being explored and may represent a novel approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• 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

Conditions T-Acute Lymphoblastic Leukemia; CD5 CAR-T