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

NCT ID: NCT05554575

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-09-30

Brief 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.

Conditions

T Cell Lymphoblastic Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BT-007 CD7 CAR-T cells in R/R T-LBL

Subjects will receive BT-007 CD7 CAR-T cells infusion on Day 0 : 100% of total dose.

Group Type: EXPERIMENTAL

BT-007 CD7 CAR-T cells

Intervention Type: BIOLOGICAL

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.

Interventions

BT-007 CD7 CAR-T cells

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioceltech Therapeutics, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiping Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongwei Xu, MD, PhD

Role: CONTACT

willyxu001@bioceltech.com

+0086-10-69739722

Facility Contacts

Role: primary

+0086-10-88121122

Other Identifiers

BT-LBL-007-v2

Identifier Type: -

Identifier Source: org_study_id