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CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies

NCT04214886 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-08-15

No results posted yet for this study

Summary

In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.

Conditions

  • B-Cell Acute Lymphoblastic Leukemia, Adult
  • B-cell Lymphoma Refractory
  • B-cell Lymphoma Recurrent

Interventions

DRUG

Fludarabine

Fludarabine is an anti-cancer drug acting as an antimetabolite that is used to treat leukemia and lymphoma cancers.

DRUG

Cyclophosphamide

Cyclophosphamide is is an anti-cancer drug acting as an alkylating agent that is used to treat leukemia and lymphoma cancers.

BIOLOGICAL

CD19-CD34 CAR transduced T cells

CD19-CD34 CAR transduced T cells are the subject's own immune cells that target B cell markers on cancer cells.

Sponsors & Collaborators

  • Leukemia Research Foundation

    collaborator UNKNOWN

  • Loyola University

    lead OTHER

Principal Investigators

  • Nasheed Hossain, MD · Loyola University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2022-08-11
Completion
2034-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04214886 on ClinicalTrials.gov