Clinical trial NCT06633354: Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
Official title: A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: T-Acute Lymphoblastic Leukemia
Keywords: CD5 CAR-T
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2024-10-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

Detailed description: In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 28 days after Treatment
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 years after Treatment
Secondary outcomes:
measure: Overall response rate ,ORR
timeFrame: Up to 12 weeks after CAR-T infusion
measure: Duration of remission ,DOR
timeFrame: Up to 1 years after CAR-T infusion
measure: Progression Free Survival, PFS
timeFrame: Up to 2 years after Treatment
measure: Overall survival, OS
timeFrame: Up to 1 years after CAR-T infusion
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: