CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma

PersonGen BioTherapeutics

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Enteropathy-type Intestinal T-cell Lymphoma

T-cell Prolymphocytic Leukemia

Peripheral T-cell Lymphoma, NOS

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type

Hepatosplenic T-cell Lymphoma

Angioimmunoblastic T-cell Lymphoma

T-cell Large Granular Lymphocytic Leukemia

Acute Myeloid Leukemia

Treatments

Biological: anti-CD7 CAR-pNK cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02742727

PG-107-002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects with CD7+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:

Eligible diseases: CD7 positive relapsed or refractory Leukemia and Lymphoma. ￚ Acute myeloid leukemia, previously identified as CD7+ ￚ Precursor T lymphoblast leukemia/lymphoma ￚ T-cell prolymphocytic leukemia ￚ T-cell large granular lymphocytic leukemia ￚ Peripheral T-cell lymphoma, NOS ￚ Angioimmunoblastic T-cell lymphoma ￚ Extranodal NK/T-cell lymphoma, nasal type ￚ Enteropathy-type intestinal T-cell lymphoma ￚ Hepatosplenic T-cell lymphoma
Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
CD7 is expressed in malignancy tissues by immuno-histochemical (IHC) or Flow cytometry.
Assessable disease as measured by laboratory and bone marrow examinations.
Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR-pNK cells.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
Ability to give informed consent.

Exclusion criteria

Patients with symptomatic central nervous system (CNS) involvement.
Pregnant or nursing women may not participate.
Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
Previously treatment with any gene therapy products.
The existence of unstable or active ulcers or gastrointestinal bleeding.
Patients with a history of organ transplantation or are waiting for organ transplantation.
Patients need anticoagulant therapy (such as warfarin or heparin).
Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).