Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma
M.D. Anderson Cancer Center
Summary
This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.
Description
Primary Objective: The primary objective of the study is to determine the efficacy of CB-derived CD70.CAR NK cell therapy in patients with primary refractory or early relapsed DLBCL and HL, as determined by the 2-year event-free survival rate. Secondary Objectives: * To determine the antitumor activity pf CB-derived CD70.CAR NK cells, as determined by the response rate (ORR) and complete response (CR) rate. * To establish the safety of this treatment. * To quantify the persistence of infused CB-derived CD70.CAR NK cells in the peripheral blood. * To conduct comprehensive immune studies by e…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18-75 years of age. 2. Diagnosis of cHL or DLBCL that is either: * Primary refractory, defined as not having achieved a CR with frontline therapy or having relapsed within 3 months. * Early relapsed (≤ 12 months) after achieving a CR to frontline therapy. 3. Tumor biopsy positive for CD70 \>/= 10% by immunohistochemistry or flow cytometry. 4. Measurable disease, defined by one or more histologically confirmed hypermetabolic lesion on PET/CT scan. 5. ECOG PS ≤ 2 (Karnofsky ≥60%). 6. Adequate blood counts (WBC \> 2K, HGB \> 8 g/dL, platelets \> 50K). 7. Creatinine…
Interventions
- DrugFludarabine
Given by IV
- DrugCyclophosphamide
Given by IV
- DrugCD70.CAR NK Cells
Given by IV Infusion
- DrugRimiducid (AP1903)
Given by IV Infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas