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CAR T-cell Therapy

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells for Minimal Residual Disease

Phase 1 & 2
Waitlist Available
Led By Jin S Im
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post t-cell infusion
Awards & highlights

Study Summary

This trial is studying a new treatment for cancer, in which T-cells are collected from the patient, modified with a new genetic material, and then infused back into the patient's body.

Eligible Conditions
  • B-Cell Acute Lymphoblastic Leukemia (ALL)
  • Minimal Residual Disease
  • Progressive Disease
  • B Acute Lymphoblastic Leukemia
  • B Cell Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post t-cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy in complete response (CR) or partial response
Incidence of adverse events (adverse events)
Optimal chimeric antigen receptor (CAR) T cell dose level
Secondary outcome measures
Overall survival
Progression-free survival
Other outcome measures
Immune reconstitution
Persistence of CAR T-cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CD19-CD22 CAR T cells)Experimental Treatment3 Interventions
Patients receive standard of care cyclophosphamide IV over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,802 Total Patients Enrolled
6 Trials studying Minimal Residual Disease
129 Patients Enrolled for Minimal Residual Disease
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,667 Total Patients Enrolled
10 Trials studying Minimal Residual Disease
299 Patients Enrolled for Minimal Residual Disease
Jin S ImPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

How many individuals are taking part in this clinical trial?

"This study is not currently looking for new patients, as the last update occurred on July 18th, 2022. The study was originally posted on November 30th, 2020. If you are exploring other studies, 3971 trials are actively enrolling participants with minimal residual disease and 928 trials for Autologous CD19/CD22 Chimeric Antigen Receptor T-cells are also recruiting."

Answered by AI

How do I qualify to take part in this experiment?

"This study is currently admitting 30 patients that meet the following criteria: Aged 6 months to 70 years old, having minimal residual disease, and total bilirubin levels below 1.5 mg/dL (except for patients with Gilbert syndrome, whose total bilirubin must be below 3.0 mg/dL). Additional requirements include an ejection fraction of 50% or above as determined by echocardiogram or multigated acquisition scan, no significant ECG findings, relapsed or refractory B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's"

Answered by AI

Could you explain what Autologous CD19/CD22 Chimeric Antigen Receptor T-cells are commonly used for?

"CAR-T therapy that targets CD19 and CD22 receptors is commonly used to treat multiple sclerosis but can also be applied to various other conditions, such as mixed-cell type lymphoma, leukemia, myelocytic, acute, retinoblastoma."

Answered by AI

Is this a clinical trial that is only for elderly patients?

"The current recruitment drive for this clinical trial is targeting patients that are older than 6 months but younger than 70 years old."

Answered by AI

Are new participants still being accepted into this research project?

"Unfortunately, this particular trial is not looking for new patients at the moment. It was originally posted on November 30th 2022 but has not been updated since July 18th of the same year. Although, there are nearly 5000 other trials that are currently enrolling participants."

Answered by AI

Are there other examples where researchers have used Autologous CD19/CD22 Chimeric Antigen Receptor T-cells in a clinical trial setting?

"Currently, there are 928 studies being conducted on Autologous CD19/CD22 Chimeric Antigen Receptor T-cells. Out of those, 165 are in Phase 3. Most of the research is taking place in Philadelphia, Pennsylvania; however, there are 28613 locations running these types of studies."

Answered by AI
~0 spots leftby Apr 2025