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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia and Lymphoma

Phase 1
Recruiting
Led By Haneen Shalabi, D.O.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have a B cell ALL or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy regimen and one salvage regimen
Participants with measurable or evaluable disease at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of relapse
Awards & highlights

Study Summary

This trial is testing the safety and effects of giving CD19/CD22-CAR T cells to children and young adults with B-cell cancer.

Who is the study for?
This trial is for children and young adults aged 3-39 with specific B-cell cancers that haven't been cured by standard treatments. Participants must have CD19 protein on their cancer cells, be in good health otherwise, able to perform daily activities, and not pregnant or breastfeeding. They should also agree to use birth control during the study.Check my eligibility
What is being tested?
The trial tests a new therapy using the patient's own T cells modified with CD19/CD22-CAR genes to fight B-cell leukemia and lymphoma. It involves taking blood or bone marrow samples, giving chemotherapy drugs Cyclophosphamide and Fludarabine, then infusing the engineered CAR T-cells back into patients.See study design
What are the potential side effects?
Possible side effects include reactions from cell infusion like fever or chills, effects of chemotherapy such as nausea or hair loss, increased risk of infections due to weakened immune system, potential organ inflammation caused by CAR T-cells attacking normal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My B cell ALL or lymphoma has not responded to at least two treatments.
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My cancer can be measured or seen on tests.
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My cancer cells show high levels of CD19.
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I am between 3 and 39 years old.
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I can do most of my daily activities on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety
Secondary outcome measures
Feasability
Overall survival
Progression-free survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansionExperimental Treatment3 Interventions
CD19/CD22-CAR-transduced T cells at MTD or highest dose administered
Group II: Dose escalationExperimental Treatment3 Interventions
CD19/CD22-CAR-transduced T cells at escalating doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,933 Total Patients Enrolled
Haneen Shalabi, D.O.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
60 Total Patients Enrolled
Nirali N Shah, M.D.Principal InvestigatorNational Cancer Institute (NCI)
13 Previous Clinical Trials
2,389 Total Patients Enrolled

Media Library

CD19/CD22 CAR T-Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03448393 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Dose escalation, Dose expansion
Acute Lymphoblastic Leukemia Clinical Trial 2023: CD19/CD22 CAR T-Cells Highlights & Side Effects. Trial Name: NCT03448393 — Phase 1
CD19/CD22 CAR T-Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03448393 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently admitted to this medical experiment?

"Affirmative. The clinicaltrials.gov website reveals that this trial, first posted on March 26th 2018, is actively searching for participants. 87 individuals must be recruited from a sole facility."

Answered by AI

Are there openings in this research program at the present time?

"That is accurate. According to clinicaltrials.gov, this medical research was initially listed on March 26th 2018 and the latest update was made on November 5th 2022. At the moment, 87 patients need to be recruited from a single site for this trial."

Answered by AI

Is eligibility for this experiment restricted to those under 35 years old?

"This trial is enrolling individuals who are between 3 and 39 years old."

Answered by AI

What is the current regulatory status of CD19/CD22 chimeric antigen receptor T-cell therapy?

"Due to the limited amount of data related to this treatment, our team has assigned a score of 1 for CD19/CD22 CAR T-Cells in terms of safety. This is because it's currently at its first stage trial phase and there are only minimal studies that have assessed efficacy."

Answered by AI

What other research has been done involving CD19/CD22 Chimeric Antigen Receptor T-Cell therapies?

"As of present, 889 studies exploring CD19/CD22 CAR T-Cells are being conducted internationally. Of those trials, 161 have reached the Phase 3 stage. The majority of these clinical trials are located in Philadelphia, Pennsylvania but there are over 28 thousand sites conducting research with this treatment modality."

Answered by AI

What conditions are CD19/CD22 CAR T-Cells commonly utilized to treat?

"CD19/CD22 CAR T-Cells is normally employed to treat multiple sclerosis, but it can be an effective treatment for various other illnesses including mixed-cell type lymphoma, leukemia, myelocytic, acute and retinoblastoma."

Answered by AI

Do I meet the requirements to take part in this clinical exploration?

"This medical study is seeking out 87 individuals aged 3 to 39 with diffuse lymphoma. To be qualified, these patients must have evidence of disease through flow cytometry, immunohistochemistry or PCR analysis; CD19 expression on more than 15% malignant cells via histology or 90% by flow cytometry (the method will depend on tissue available); Karnofsky/Lansky score over 50%; leukocyte and platelet count exceeding 750/mcL* and 50,000 mcL*, respectively; a B cell ALL diagnosis that has been unresponsive to standard chemotherapy regimens plus salvage therapy for which there are no other cur"

Answered by AI
Recent research and studies
~29 spots leftby Dec 2025