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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03448393
Other study ID # 180059
Secondary ID 18-C-0059
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 26, 2018
Est. completion date December 31, 2040

Study information

Verified date June 4, 2024
Source National Institutes of Health Clinical Center (CC)
Contact NCI Pediatric Leukemia, Lymphoma Transpl
Phone (240) 760-6970
Email ncilltct@mail.nih.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: B-cell leukemias and lymphomas are cancers that are often difficult to treat. The primary objective of this study is to determine the ability to take a patient's own cells (T lymphocytes) and grow them in the laboratory with the CD19/CD22-CAR receptor gene through a process called 'lentiviral transduction (also considered gene therapy) and growing them to large numbers to use as a treatment for hematologic cancers in children and young adults.. Researchers want to see if giving modified CD19/CD22-CAR T cells to people with these cancers can attack cancer cells. In addition, the safety of giving these gene modified cells to humans will be tested at different cell doses. Additional objectives are to determine if this therapy can cause regression of B cell cancers and to measure if the gene modified cells survive in patients blood. Objective: To study the safety and effects of giving CD19/CD22-CAR T cells to children and young adults with B-cell cancer. Eligibility: People ages 3-39 with certain cancers that have not been cured by standard therapy. Their cancer tissue must express the CD19 protein. Design: A sample of participants blood or bone marrow will be sent to NIH and tested for leukemia. Participants will be screened with: Medical history Physical exam Urine and blood tests (including for HIV) Heart and eye tests Neurologic assessment and symptom checklist. Scans, bone marrow biopsy, and/or spinal tap Some participants will have lung tests. Participants will repeat these tests throughout the study and follow-up. Participants will have leukapheresis. Blood will be drawn from a plastic tube (IV) or needle in one arm then go through a machine that removes lymphocytes. The remaining blood will be returned to the participant s other arm. Participants will stay in the hospital about 2 weeks. There they will get: Two chemotherapy drugs by IV Their changed cells by IV Standard drugs for side effects Participants will have frequent follow-up visits for 1 year, then 5 visits for the next 4 years. Then they will answer questions and have blood tests every year for 15 years. ...


Description:

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Study Design


Intervention

Biological:
CD19/CD22 CAR T-Cells
CD19/CD22 cells will be infused on Day 0 after induction chemotherapy regimen.
Drug:
Fludarabine
Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose)
Cyclophosphamide
Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion on Day -2.

Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Safety analyses will consist of tabulations of grades of toxicity by type of toxicity. End of treatment
Secondary Feasability Number of patients which can successfully manufacture the targeted dose number 28 days post treatment completion
Secondary Overall survival Overall survival (OS) will be determined as the time from the start of the preparative regimen until death Death
Secondary Progression-free survival Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first. Time of relapse
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