Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

Trial Title: 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

Condition: T Cell Lymphoma
T Cell Leukemia
T-cell Acute Lymphoblastic Leukemia
T-Cell Lymphoma of CNS
T Cell Prolymphocytic Leukemia
T Cell Childhood ALL

Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Leukemia, T-Cell
Leukemia, Prolymphocytic
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Prolymphocytic, T-Cell

Conditions: Keywords:
CAR-T
CD5
CD7
ETP-ALL

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD5 and CD7 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD5 and CD7 CAR-T cells.

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group.

Intervention:

Intervention type: Biological
Intervention name: CD5/CD7 CAR-T
Description: The intervention in this clinical trial involves a novel approach using CD5/CD7 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD5/CD7 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD5/CD7 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD5/CD7 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.
Arm group label: Sequential CAR-T Cells Targeting (CD5/CD7 CAR T cells, chemotherapy)

Other name: EB-BH2026

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.

Detailed description: Acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there are limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive Sequential CAR-T Cells Targeting CD5/CD7 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ CD7+ relapsed or refractory acute leukemia.

Criteria for 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).

Gender: All

Minimum age: 2 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: District One Hospital

Address:
City: Beijing
Zip: 086-373
Country: China

Status: Recruiting

Contact:
Last name: SAMI XI, dr

Phone: +14012275001
Email: SFM@districtonehospital.com

Start date: July 10, 2024

Completion date: December 28, 2026

Lead sponsor:
Agency: Essen Biotech
Agency class: Other

Source: Essen Biotech

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06420076