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Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies

NCT02315612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-28

No results posted yet for this study

Summary

Background:

\- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells.

Objective:

\- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective.

Eligibility:

\- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy.

Design:

* Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests.
* Participants may have eye and neurologic exams.
* Participants will get a central venous catheter or a catheter in a large vein.
* Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm.
* The cells will be changed in a laboratory.
* Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this.
* All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone.
* Participants will have many blood tests. They may repeat some screening exams.
* Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams.
* Participants will have follow-up for 15 years.

Conditions

Interventions

BIOLOGICAL

CD22-CAR

CD22-CAR cells will be infused on Day 0 after induction chemotherapy regimen.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nirali N Shah, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-12
Primary Completion
2019-04-03
Completion
2024-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02315612 on ClinicalTrials.gov