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Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma

NCT04029038 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-21

No results posted yet for this study

Summary

This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.

Conditions

  • CD19 Positive
  • CD22 Positive
  • Minimal Residual Disease
  • Progressive Disease
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jin S Im · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-11-16
Completion
2022-11-16
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 NCT04029038 on ClinicalTrials.gov