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CAR T-cell Therapy

Dual CAR T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1 & 2
Recruiting
Led By Regina Myers, MD
Research Sponsored by Stephan Grupp MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with documented CD19+ and/or CD22+ ALL/LLy
Patients with relapsed or refractory ALL/LLy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will test two new treatments for childhood leukemia to see if they're safe and effective.

Who is the study for?
This trial is for children and young adults (0-29 years) with advanced B cell Acute Lymphoblastic Leukemia who have either not responded well to previous CAR T cell therapy or have relapsed/refractory ALL/LLy. Participants must show CD19+ and/or CD22+ tumor expression, be in good enough health, agree to birth control if applicable, and cannot be pregnant or nursing.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of two CAR T cell therapies given together: huCART19 and CART22-65s. These are specialized treatments designed to target leukemia cells in patients whose disease has been difficult to treat with standard options.See study design
What are the potential side effects?
CAR T cell therapies can cause side effects like fever, fatigue, headache, difficulty breathing, low blood pressure, rapid heart rate; they may also affect normal blood cells leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia cells test positive for CD19 or CD22.
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My leukemia has returned or is not responding to treatment.
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I can do most activities but may need help.
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I am 29 years old or younger.
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My previous cell therapy targeting B cells didn't work well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years 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 of CART22-65s and huCART19 co-administration
Safety of CART22-65s and huCART19 co-administration
Secondary outcome measures
Anti-tumor response due to CART22-65s and huCART19 co-administration
Bioreactivity of CART22-65s and huCART19 when co-administered
CAR T Cell Therapy Persistence
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion ArmExperimental Treatment2 Interventions
If at least one dose level of phase 1 is determined to be safe, the phase 2 dose expansion phase of the trial will be opened to enrollment. Subjects will receive the highest dose of CART 22-65s and huCART19 cells that were determined to be safe. 2 cohorts are planned: Cohort A (relapsed/refractory, CAR T cell naïve) & Cohort B (prior treatment with a prior CAR T cell product).
Group II: Dose Finding ArmExperimental Treatment2 Interventions
Phase 1 will evaluate the safety of co-administration of CART22-65s with huCART19 in patients who experienced a disease relapse after prior CAR T cell therapy. There is no planned dose escalation but a dose-deescalation will be made based on the incidence of Dose Limiting Toxicities

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,994 Previous Clinical Trials
42,879,163 Total Patients Enrolled
Stephan Grupp MD PhDLead Sponsor
4 Previous Clinical Trials
220 Total Patients Enrolled
Regina Myers, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

CART22-65s (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05674175 — Phase 1 & 2
B-Cell Lymphoma Research Study Groups: Dose Finding Arm, Expansion Arm
B-Cell Lymphoma Clinical Trial 2023: CART22-65s Highlights & Side Effects. Trial Name: NCT05674175 — Phase 1 & 2
CART22-65s (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674175 — Phase 1 & 2

Frequently Asked Questions

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

What is the extent of individual participation in this clinical research?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this research is actively trying to recruit candidates. It was posted on January 25th 2023 and last updated the same day. A total of 93 patients must be enrolled from a single site."

Answered by AI

Is there a recruitment period open for participants of this study?

"Affirmative. According to the clinicaltrials.gov record, this medical study is actively seeking patients since it was first posted on January 25th 2023 and updated on the same day. 93 participants must be acquired from a single site for the trial to commence."

Answered by AI

What effects are investigators trying to ascertain from this research?

"The principal objective of this year-long trial is to examine the safety profile of CART22-65s and huCART19 co-administration. Auxiliary goals include assessing the persistence of CAR T cell therapy through PCR or flow cytometry, evaluating anti-tumor responses via negative minimal residual disease (MRD) at day 28, as well as measuring relapse free survival in both CAR naive and exposed participants with poor response to prior B cell directed engineered cell therapy."

Answered by AI
~62 spots leftby Jan 2027