Trials / Unknown
UnknownNCT02944162
CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML
Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
Detailed description
PRIMARY OBJECTIVES: Determine the safety and feasibility of the chimeric antigen receptor NK92 cells transduced with the anti-CD33 vector (referred to as anti-CD33 CAR-NK cells). SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-leukemia response due to anti-CD33 CAR-NK cell infusions. II. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by anti-CD33 CAR-NK in vitro. III. Determine if cellular or humoral host immunity develops against the murine anti-CD33. OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD33 CAR-NK (coupled with CD28, CD137 and CD3 zeta signalling domains) vector-transduced NK92 cell line on days 0,3, and 5 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
Conditions
- Acute Myelogenous Leukemia
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia With Maturation
- Acute Myeloid Leukemia Without Maturation
- ANLL
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | anti-CD33 CAR-NK cells | The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33. |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-09-01
- Completion
- 2018-09-01
- First posted
- 2016-10-25
- Last updated
- 2016-12-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02944162. Inclusion in this directory is not an endorsement.