At a glance
ClinicalIndex Comparison Record- ✓CD19+ B-lymphoid malignancy (ALL, CLL, or NHL) with either ≥2 prior lines of chemoimmunotherapy/targeted therapy with persistent disease, OR relapsed disease after standard therapy or stem cell transplant
- ✓At least 3 weeks from last cytotoxic chemotherapy; tyrosine kinase inhibitors/other targeted therapies may continue until ≥2 weeks before lymphodepleting chemotherapy
- ✓Karnofsky/Lansky Performance Scale >70
- ✓Age 7–80 years
- ✕Positive beta-hCG in women of childbearing potential (not postmenopausal ≥24 months, no prior surgical sterilization) or lactating females
- ✕Known positive HIV serology
- ✕Grade ≥3 toxicity from previous treatment
- ✕Active fungal, bacterial, viral, or other infection requiring IV antimicrobials (simple UTI and uncomplicated bacterial pharyngitis permitted if responding to treatment)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose Escalation Study Phase I/II of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction With Lymphodepleting Chemotherapy in Patients With Relapsed/Refractory B-Lymphoid Malignancies
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 3 other interventions for B-Lymphoid Malignancies and 3 related conditions. Completed, enrolled 49 participants across 1 site.
Detailed Summary
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell transplant patients with relapsed (has returned) and/or refractory (has not responded to treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The safety of this treatment will also be studied. This is an investigational study. The making of and infusion of genetically changed NK cells and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially available for use in this type of disease. They are currently being used for research purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and mesna) are commercially available and FDA approved. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Study Details
Timeline
Interventions
30 mg/m2 by vein on Days -5 to -3.
300 mg/m2 by vein on Days -5 to -3.
300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein. Starting dose: 10E5
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.