Chimeric Antigen Receptor T-Cell (CAR-T) Cells in Patients With R/R T-LBL

Trial Title: Chimeric Antigen Receptor T-Cell (CAR-T) Cells in Patients With R/R T-LBL

NCT ID: NCT05554575

Condition: T Cell Lymphoblastic Lymphoma

Conditions: Official terms:
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study type: Interventional

Study phase: Phase 1

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: BT-007 CD7 CAR-T cells
Description: T cells purified from the peripheral blood mononuclear cell (PBMC) of subjects or subjects' relatives which depend on their conditions, transduced with 4-1BB/CD3ζ lentiviral vector, expanded in vitro for future administration.
Arm group label: BT-007 CD7 CAR-T cells in R/R T-LBL

Summary: This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).

Detailed description: Primary objective: To investigate the safety and efficacy of CD7 CAR-T cells in the treatment of patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL). Secondary objective: To assess the patient's quality of life after receiving the treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patients with CD7 positive T-cell lymphoma confirmed by histology; 2. Relapsed refractory patients who received at least one line of systemic chemotherapy in the past; 3. At least one measurable target lesion; 4. Age: 18-70 years old (including 18 and 70 years old); 5. The expected survival period is more than 3 months; 6. Eastern Cooperative Oncology Group (ECOG) score 0-1; 7. Important organ functions met: left ventricular ejection fraction≥50% according to cardiac ultrasound; Serum Cr≤1.25 times the upper limit of normal range (ULN) or endogenous creatinine clearance≥45mL/min (Cockcroft Gault formula); ALT and AST≤3 times ULN, TBIL≤1.5 times ULN; 8. Blood routine: hemoglobin (Hgb)≥80g/L, neutrophil count (ANC)≥1×10^9/L, platelet PLT≥50×10^9/L； 9. Coagulation function: International standardized ratio (INR)≤1.5 times ULN; Activated partial thromboplastin time (APTT)≤1.5 times ULN (unless the subject is receiving anticoagulant treatment, and prothrombin time (PT)/INR and APTT are within the expected range of anticoagulant treatment at the time of screening); 10. The pregnancy test of women of childbearing age must be negative; Both male and female patients need to agree to use effective contraceptive measures during the treatment period and within the following 1 year; 11. Participate in this test voluntarily and sign the informed consent. Exclusion Criteria: 1. Used immunosuppressive agents or therapeutic doses of corticosteroids (defined as prednisone>20mg or equivalent dose) within one week before blood collection, or used drugs that stimulate bone marrow hematopoiesis, such as Human Granulocyte Colony Stimulating Factor (G-CSF); But physiological substitution, topical or inhaled steroids are permitted; 2. Uncontrolled systemic active fungi, bacteria, viruses or other infections; 3. Active hepatitis B (HBV DNA>500IU/mL), hepatitis C (HCV RNA positive) or human immunodeficiency virus (HIV) antibody positive; 4. Central nervous system invasion, or central nervous system disease history, such as epilepsy, cerebrovascular disease, etc; 5. Pregnant or lactating women, or patients do not agree to use effective contraceptives during treatment and within the following 1 year; 6. Receiving allogeneic hematopoietic stem cell transplantation or organ transplantation; 7. Previous history of other malignant tumors. Patients with cured skin basal or squamous cell carcinoma and cervical carcinoma in situ at any time before the study were not included; Patients with other tumors not listed above, but which have been cured by surgery but not by other further treatment measures, and disease-free survival≥5 years, can be included in the study; 8. Patients with primary immunodeficiency or autoimmune diseases, but asymptomatic hypothyroidism, or well controlled type I diabetes can participate in this study; 9. Patients who participated in other clinical trials within 4 weeks before blood collection; 10. The investigator considers that there are other factors that are not suitable for inclusion or affect the subjects to participate in or complete the study.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:

Phone: +0086-10-88121122

Start date: October 2022

Completion date: September 2024

Lead sponsor:
Agency: Bioceltech Therapeutics, Ltd.
Agency class: Industry

Source: Bioceltech Therapeutics, Ltd.

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

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05554575