Phase I Trial of Anti-CD20, Anti-CD19, Anti-CD22 CAR (CAR20.19.22) T-cells for Relapsed, Refractory B-cell Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Non-hematologic Adverse Events after Infusion
Study Overview
Brief Summary
In this phase I study, the investigators will first evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL).
Detailed Description
This is a phase I, interventional, open label, dose-finding treatment study designed to evaluate the safety and efficacy CAR20.19.22 T-cells in adult patients with B-cell malignancies that have failed prior therapies.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 0.75x10^6 cells/kg CAR20.19.22 cells (Biological)
Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 1x10^6 cells/kg CAR20.19.22 cells (Biological)
Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 2.5x10^6 cells/kg CAR20.19.22 cells (Biological)
Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 5x10^6 cells/kg CAR20.19.22 cells (Biological)
Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 0.75x10^6 cells/kg CAR20.19.22 cells (Biological)
Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 1x10^6 cells/kg CAR20.19.22 cells (Biological)
Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 2.5x10^6 cells/kg CAR20.19.22 cells (Biological)
Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22
The investigators will start at a dose of 1.0x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Intervention: 5x10^6 cells/kg CAR20.19.22 cells (Biological)
Outcomes
Primary Outcomes
Number of Non-hematologic Adverse Events after Infusion
Time Frame: 28 days after infusion
Occurrence of adverse events will be defined as non-hematologic Grade 3/4 toxicity grade per NCI CTCAE version 5.0.
Number of grade 3-4 cytokine release syndrome (CRS).
Time Frame: 28 days after infusion
Grade 3-4 CRS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Number of grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS)
Time Frame: 28 days after infusion
Grade 3-4 ICANS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nirav Shah
Associate Professor
Medical College of Wisconsin