CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma

Phase 1

• Conditions: Acute Myeloid Leukemia; T-cell Prolymphocytic Leukemia; Extranodal NK/T-cell Lymphoma, Nasal Type; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Peripheral T-cell Lymphoma, NOS; Hepatosplenic T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; T-cell Large Granular Lymphocytic Leukemia; Enteropathy-type Intestinal T-cell Lymphoma
• Interventions: Biological: anti-CD7 CAR-pNK cells

• Registration Number: NCT02742727
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-04
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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:

1. 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
2. Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
3. CD7 is expressed in malignancy tissues by immuno-histochemical (IHC) or Flow cytometry.
4. Assessable disease as measured by laboratory and bone marrow examinations.
5. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
6. 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.
7. 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.
8. Ability to give informed consent.

Exclusion Criteria

1. Patients with symptomatic central nervous system (CNS) involvement.
2. Pregnant or nursing women may not participate.
3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. 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.
5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
6. Previously treatment with any gene therapy products.
7. The existence of unstable or active ulcers or gastrointestinal bleeding.
8. Patients with a history of organ transplantation or are waiting for organ transplantation.
9. Patients need anticoagulant therapy (such as warfarin or heparin).
10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-pNK Cell immunotherapy	anti-CD7 CAR-pNK cells	Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion.

Primary Outcome Measures

Name	Time	Method
Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells	2 years	Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures

Name	Time	Method
Clinical response to CD7 CAR-pNK cell infusions	Safety follow-up is 100 days from last CAR-pNK infusion	Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment.
Determine the existence of CD7-CAR-pNK in vivo	1 year

Trial Locations

Locations (1)

PersonGen BioTherapeutics (Suzhou) Co., Ltd.; 🇨🇳 Suzhou, Jiangsu, China