Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma

This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.

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Key information

Conditions

T Cell Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type T-cell Leukemia

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Boren Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
Male or female, aged 0-70 years
No serious allergic constitution
Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
Have life expectancy of at least 60 days based on investigator's judgement
CD7 positive in bone marrow or peripheral blood or immunohistochemistry
Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Intracranial hypertension or disorder of consciousness
Symptomatic heart failure or severe arrhythmia
Symptoms of severe respiratory failure
Complicated with other types of malignant tumors
Diffuse intravascular coagulation
Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
Suffering from septicemia or other uncontrollable infections
Patients with uncontrollable diabetes
Severe mental disorders
Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
Have received organ transplantation (excluding hematopoietic stem cell transplantation);
Reproductive-aged female patients with positive blood HCG test
Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis

Treatment and study plan

chimeric antigen receptor T cell treatment

Biological

Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.

Primary outcomes

DLT rate

Time frame: 21 days

The DLT rate to the CAR-T treatment

Sponsors and collaborators

Lead sponsor

Beijing Boren Hospital

Other

Registry information

Official study title

Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 12, 2021
Registry last updated: Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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