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CAR T-cell Therapy

CART22 Therapy for B-Cell Leukemia

Q: What is the current number of participants participating in this research?

Affirmative. Per the clinicaltrials.gov page, this medical trial is presently seeking participants. It was first published on January 13th 2016 and updated most recently on January 19th 2022. This research project needs to enlist 15 individuals from a single site.

Q: Are seniors excluded from participating in this clinical investigation?

This research program necessitates that suitable candidates are between 1 year to 24 years old. There is an abundance of clinical trials for minors, with 437 available studies, and a plethora of trial options for seniors as well - 1233 in total.

Q: Has the U.S. Food & Drug Administration sanctioned CART22 cells that have been genetically altered using a lentiviral vector to express anti-CD22 scFv TCRz:41BB?

Since this is a Phase 1 trial and there is scant clinical evidence regarding the safety of CART22 cells transduced with lentiviral vector to express anti-CD22 scFv TCRz:41BB, our team at Power has rated its safety as a score of one.

Q: Is there presently an opportunity for patients to join this experiment?

Affirmative. The information on clinicaltrials.gov states that this endeavor is currently enrolling participants, having been originally posted back in January 2016 and last edited on the 19th of Jan 2022. 15 individuals from a single medical centre are sought for inclusion in this trial.

Q: Which individuals are eligible to participate in this research trial?

This clinical trial is recruiting 15 individuals between the ages of one year and 24 years with a diagnosis of chronic B-cell <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, lymphocytic leukemia, or related disorders. To be considered for inclusion in this study, they must also meet any number of criteria including: second or greater bone marrow relapse; failure to respond to multiple chemotherapy regimens; intolerance to tyrosine kinase inhibitors if diagnosed with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ <a href="https://www.withpower.com/clinical-trials/all">ALL</a>); comorbid diseases; contraindications to allogeneic stem cell transplantation conditioning regimen; lack of suitable donor match; prior stem cell transplantations that

Phase 1

Recruiting

Led By Stephan Grupp, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of CD22 tumor expression in bone marrow or peripheral blood by flow cytometry at relapse

Relapsed or refractory B-cell ALL meeting specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 year

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for kids with leukemia that has relapsed or is resistant to other treatments.

Who is the study for?

This trial is for children and young adults aged 1-29 with relapsed or refractory B-cell acute lymphoblastic leukemia. Participants must have adequate organ function, documented CD22 tumor expression, and agree to birth control if applicable. Excluded are those with HIV, active hepatitis B/C, certain CNS diseases, use of systemic steroids/immunosuppressants (with exceptions), pregnancy/nursing women, recent investigational drug use.Check my eligibility

What is being tested?

The study tests a single dose of CART22 cells in pediatric patients. These cells are modified T cells engineered to target CD22 on leukemia cells using a special receptor called 'chimeric antigen receptors' with co-stimulatory domains TCRζ/4-1BB.See study design

What are the potential side effects?

Potential side effects may include immune system reactions leading to inflammation in various organs, infusion-related reactions similar to allergic responses, fatigue due to the body's reaction to treatment, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer shows CD22 expression in my latest tests.

Select...

My B-cell ALL has returned or didn't respond to treatment.

Select...

I am between 1 and 29 years old.

Select...

I can do most activities but may need help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS)

Secondary outcome measures

Describe cause of death (COD) when appropriate

Describe response in terms of minimal residual disease (MRD).

Duration of remission (DOR)

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CART22 cellsExperimental Treatment1 Intervention

Subjects <50kg will receive 0.2-1 x 10^7 CART22 cells/kg as a split dose over three days as follows: Day 1, 10% fraction: 0.2-1x10^6 CART22 cells/kg Day 2, 30% fraction: 0.6-3x10^6 CART22 cells/kg Day 3, 60% fraction: 1.2-6x10^6 CART22 cells/kg Subjects ≥50kg will receive 1-5x10^8 CART22 cells as a split dose over three days as follows: Day 1, 10% fraction: 1-5x10^7 Day 2, 30% fraction: 0.3-1.5x10^8 Day 3, 60% fraction: 0.6-3x10^8

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,272 Total Patients Enrolled

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,583,005 Total Patients Enrolled

Stephan Grupp, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia

1 Previous Clinical Trials

81 Total Patients Enrolled

Media Library

CART22 cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02650414 — Phase 1

B-Cell Leukemia Research Study Groups: CART22 cells

B-Cell Leukemia Clinical Trial 2023: CART22 cells Highlights & Side Effects. Trial Name: NCT02650414 — Phase 1

CART22 cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02650414 — Phase 1

Frequently Asked Questions

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

What is the current number of participants participating in this research?

"Affirmative. Per the clinicaltrials.gov page, this medical trial is presently seeking participants. It was first published on January 13th 2016 and updated most recently on January 19th 2022. This research project needs to enlist 15 individuals from a single site."

Answered by AI

Are seniors excluded from participating in this clinical investigation?

"This research program necessitates that suitable candidates are between 1 year to 24 years old. There is an abundance of clinical trials for minors, with 437 available studies, and a plethora of trial options for seniors as well - 1233 in total."

Answered by AI

Has the U.S. Food & Drug Administration sanctioned CART22 cells that have been genetically altered using a lentiviral vector to express anti-CD22 scFv TCRz:41BB?

"Since this is a Phase 1 trial and there is scant clinical evidence regarding the safety of CART22 cells transduced with lentiviral vector to express anti-CD22 scFv TCRz:41BB, our team at Power has rated its safety as a score of one."

Answered by AI

Is there presently an opportunity for patients to join this experiment?

"Affirmative. The information on clinicaltrials.gov states that this endeavor is currently enrolling participants, having been originally posted back in January 2016 and last edited on the 19th of Jan 2022. 15 individuals from a single medical centre are sought for inclusion in this trial."

Answered by AI

Which individuals are eligible to participate in this research trial?

"This clinical trial is recruiting 15 individuals between the ages of one year and 24 years with a diagnosis of chronic B-cell leukemia, lymphocytic leukemia, or related disorders. To be considered for inclusion in this study, they must also meet any number of criteria including: second or greater bone marrow relapse; failure to respond to multiple chemotherapy regimens; intolerance to tyrosine kinase inhibitors if diagnosed with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL); comorbid diseases; contraindications to allogeneic stem cell transplantation conditioning regimen; lack of suitable donor match; prior stem cell transplantations that"

Answered by AI

Recent research and studies

Nature MedicineJournal

Antigen-independent Activation Enhances the Efficacy of 4-1bb-costimulated CD22 CAR T Cells

Singh, Nathan, Noelle V. Frey, Boris Engels, David M. Barrett, Olga Shestova, Pranali Ravikumar, Katherine D. Cummins, et al.. 2021. “Antigen-independent Activation Enhances the Efficacy of 4-1bb-costimulated CD22 CAR T Cells”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01326-5.

clinicaltrials.govStudy

CD22 Redirected Autologous T Cells for ALL

2016. "CD22 Redirected Autologous T Cells for ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02650414.