CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies

Phase 1

Active, not recruiting

• Conditions: B-cell Non Hodgkin Lymphoma; B-cell Chronic Lymphocytic Leukemia
• Interventions: Biological: 0.75x10^6 cells/kg CAR20.19.22 cells; Biological: 5x10^6 cells/kg CAR20.19.22 cells; Biological: 2.5x10^6 cells/kg CAR20.19.22 cells; Biological: 1x10^6 cells/kg CAR20.19.22 cells

• Registration Number: NCT05094206
• Lead Sponsor: Medical College of Wisconsin

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 Timeline

• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2021-10-17
• Study First Posted: 2021-10-26
• Study Start: 2022-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22	0.75x10^6 cells/kg CAR20.19.22 cells	The investigators will start at a dose of 1x10\^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22	5x10^6 cells/kg CAR20.19.22 cells	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.
Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22	0.75x10^6 cells/kg CAR20.19.22 cells	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.
Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22	2.5x10^6 cells/kg CAR20.19.22 cells	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.
Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22	5x10^6 cells/kg CAR20.19.22 cells	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.
Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22	1x10^6 cells/kg CAR20.19.22 cells	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.
Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22	1x10^6 cells/kg CAR20.19.22 cells	The investigators will start at a dose of 1x10\^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22	2.5x10^6 cells/kg CAR20.19.22 cells	The investigators will start at a dose of 1x10\^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.

Primary Outcome Measures

Name	Time	Method
Number of Non-hematologic Adverse Events after Infusion	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).	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)	28 days after infusion	Grade 3-4 ICANS as graded per the recent Transplant and Cell Therapy (TCT) consensus criteria.

Trial Locations

Locations (1)

Medical College of Wisconsin and Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States