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CAR T-cell Therapy

CART22 + huCART19 for Acute Lymphoblastic Leukemia

Phase 1

Waitlist Available

Led By Noelle Frey, MD

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 expression on malignant cells at relapse for Cohort 1 and documentation of CD22 and/or CD19 for Cohort 2

Patients with relapsed or refractory B cell ALL meeting specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people with B-cell acute lymphoblastic leukemia that has relapsed or is refractory to previous treatments.

Who is the study for?

Adults over 18 with B-cell ALL that's come back or hasn't responded to treatment can join. They must have tried a tyrosine kinase inhibitor if they have Ph+ ALL, and their organs must work well. People with CNS3 disease can only join if it's under control.Check my eligibility

What is being tested?

The trial is testing CART22-65s cells alone or combined with huCART19 after chemotherapy to see if they're safe and workable for treating relapsed/refractory B-ALL in adults. It's an early-phase study where everyone knows what treatment they're getting.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells, symptoms from low blood cell counts due to chemotherapy, and infusion-related reactions like fever or chills.

Eligibility Criteria

Inclusion Criteria

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

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My cancer cells show CD22 for Cohort 1 or CD22/CD19 for Cohort 2.

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My B cell ALL has come back or didn't respond to treatment.

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My kidney, liver, and heart functions are within normal ranges.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I have no health issues preventing leukapheresis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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

Assess the safety of CART22-65s in ALL subjects using the common terminology criteria of adverse events (CTCAE) v5.0.

Assess the safety of combination CART22-65s and huCART19 in relapsed/refractory ALL Subjects using the common terminology criteria of adverse events (CTCAE) v5.0.

Secondary outcome measures

CAR T cell kinetics

Determine antigen expression and normal B cell levels in response to CAR T cells

Evaluate bioactivity of CAR T cells

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CART22-65s monotherapyExperimental Treatment1 Intervention

Group II: CART22-65s in combination with huCART19Experimental Treatment2 Interventions

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,037 Total Patients Enrolled

Noelle Frey, MDPrincipal InvestigatorUniversity of Pennsylvania

9 Previous Clinical Trials

187 Total Patients Enrolled

Media Library

CART22-65s cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03620058 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: CART22-65s in combination with huCART19, CART22-65s monotherapy

Acute Lymphoblastic Leukemia Clinical Trial 2023: CART22-65s cells Highlights & Side Effects. Trial Name: NCT03620058 — Phase 1

CART22-65s cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03620058 — Phase 1

Frequently Asked Questions

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

What are the chief aims of this investigation?

"This 15-month clinical trial is primarily assessing the safety of CART22-65s by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The secondary objectives include evaluating bioactivity via Luminex-based analysis, determining tumor response through Event Free Survival (EFS), and gauging antigen expression and B cell levels before and after CAR T infusion with flow cytometry."

Answered by AI

Does CART22-65s cells possess regulatory approval from the FDA?

"Due to the lack of clinical evidence, CART22-65s cells were rated a 1 on our safety scale. This is because it is currently undergoing Phase 1 trials where data regarding efficacy and safety has not been fully established."

Answered by AI

Are participants being admitted to this experiment at present?

"According to clinicaltrials.gov, this medical experiment is not accepting participants at present. Initially posted on September 27th 2018 and last modified February 18th 2022, its recruitment period has since expired; nonetheless, there are 1,495 other studies that people can join right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CART22 Alone or in Combination With huCART19 for ALL

2018. "CART22 Alone or in Combination With huCART19 for ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03620058.