Acute Myeloid LeukemiaPhase 1/2NCT02742727
CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma
A Phase 1/2 study testing anti-CD7 CAR-pNK cells in people with Acute Myeloid Leukemia and Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, T-cell Prolymphocytic Leukemia
- What is being tested?
- anti-CD7 CAR-pNK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215123
Lin Yang, Ph.D., 86-512-65922190, info@persongen.com
Yangyi Bao, MD
About this study
Official title: Chimeric Antigen Receptor-Modified pNK Cells for CD7 Positive Relapsed or Refractory Leukemia and Lymphoma
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.
- Conditions
- Acute Myeloid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocytic Leukemia, Peripheral T-cell Lymphoma, NOS, Angioimmunoblastic T-cell Lymphoma
- Being tested
- anti-CD7 CAR-pNK cells
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Prolymphocytic, T-Cell, Leukemia, Large Granular Lymphocytic, Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Extranodal NK-T-Cell, Enteropathy-Associated T-Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD7 CAR-pNK cellsBiological
Also called chimeric antigen receptor NK cells with specificity for CD7
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7.
| Study group | Role | What they receive |
|---|---|---|
| CAR-pNK Cell immunotherapy | Experimental | Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion. Receives: Biological: anti-CD7 CAR-pNK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells
Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 2 years
Secondary outcomes (2)
Clinical response to CD7 CAR-pNK cell infusions
Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment.
Measured: Safety follow-up is 100 days from last CAR-pNK infusion
Determine the existence of CD7-CAR-pNK in vivo
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Hefei, Hefei Binhu Hospital
- Responsible party
- Sponsor
- Investigators
- Lin Yang, Ph.D., Principal investigator, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742727
- Sponsor's protocol ID
- PG-107-002
- Status last verified
- Dec 2016
- First submitted
- 31 Mar 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.
PubMed 28054442
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimeric Antigen Receptor-Modified pNK Cells for CD7 Positive Relapsed or Refractory Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT02742727
- Acronym / sponsor ID
- PG-107-002
- Conditions
- Acute Myeloid Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocytic Leukemia, Peripheral T-cell Lymphoma, NOS, Angioimmunoblastic T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Hefei, Hefei Binhu Hospital
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-pNK Cell immunotherapy | Experimental | Biological: anti-CD7 CAR-pNK cellsEnrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-CD7 CAR-pNK cellsAlso: chimeric antigen receptor NK cells with specificity for CD7The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7. | Biological | CAR-pNK Cell immunotherapy |
Primary outcome
Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells
Time frame: 2 years
Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 secondary outcomes
Clinical response to CD7 CAR-pNK cell infusions
Time frame: Safety follow-up is 100 days from last CAR-pNK infusion
Determine the existence of CD7-CAR-pNK in vivo
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Derived from this study: PubMed 28054442Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.
- Individual participant dataSharing planned: Yes
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Yang, Ph.D. principal investigator
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anti-CD7 CAR-pNK cells in people with Acute Myeloid Leukemia and Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang, Ph.D. (86-512-65922190, info@persongen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.