NCT06420076 Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells
| NCT ID | NCT06420076 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Essen Biotech |
| Condition | T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-07-10 with a primary completion date of 2025-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06420076 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 90 Years, studying T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06420076 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06420076 currently recruiting?
Yes, NCT06420076 is actively recruiting participants. Contact the research team at clinical-trials@essen-biotech.com for enrollment information.
Where is the NCT06420076 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06420076 clinical trial?
NCT06420076 is sponsored by Essen Biotech. The trial plans to enroll 60 participants.