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

NCT05094206 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-09-19

No results posted yet for this study

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).

Conditions

  • B-cell Non Hodgkin Lymphoma
  • B-cell Chronic Lymphocytic Leukemia

Interventions

BIOLOGICAL

0.75x10^6 cells/kg CAR20.19.22 cells

Dose escalation: CAR20.19.22 cells will be administered at one of three dose levels either fresh or thawed after cryopreservation by IV injection. Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.

BIOLOGICAL

1x10^6 cells/kg CAR20.19.22 cells

CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.

BIOLOGICAL

2.5x10^6 cells/kg CAR20.19.22 cells

CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.

BIOLOGICAL

5x10^6 cells/kg CAR20.19.22 cells

CAR20.19.22 cells will be administered at one of four dose levels either fresh or thawed after cryopreservation by IV injection. The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6.

BIOLOGICAL

Dose expansion: The maximum tolerated dose of CAR20.19.22 cells

Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10\^6 cells/kg, 1x10\^6 cells/kg, 2.5x10\^6 cells/kg or 5x10\^6 cells/kg.

Sponsors & Collaborators

  • Miltenyi Biotec, Inc.

    collaborator INDUSTRY

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Nirav Shah, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-01-29
Completion
2024-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05094206 on ClinicalTrials.gov