Actively Recruiting

Phase 1
Phase 2
Age: 0 - 29Years
All Genders
NCT05674175

Co-administration of CART22-65s and huCART19 for B-ALL

Led by Stephan Grupp MD PhD · Updated on 2026-03-27

93

Participants Needed

1

Research Sites

335 weeks

Total Duration

On this page

Sponsors

S

Stephan Grupp MD PhD

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

CONDITIONS

Official Title

Co-administration of CART22-65s and huCART19 for B-ALL

Who Can Participate

Age: 0 - 29Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Diagnosis of CD19-positive and/or CD22-positive Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
  • For Cohort A: relapsed or refractory ALL/LLy
  • For Cohort B: poor response to prior B cell targeted engineered cell therapy
  • History of Central Nervous System 3 disease allowed if responsive to therapy
  • Documentation of CD19 and/or CD22 tumor expression by flow cytometry at last detectable disease
  • Age between 0 and 29 years
  • Adequate organ function
  • Performance status with Lanksy or Karnofsky score 50 or higher
  • Agreement to use acceptable birth control methods if of reproductive potential
Not Eligible

You will not qualify if you...

  • Active hepatitis B or hepatitis C infection
  • HIV infection
  • Active acute or chronic Graft Versus Host Disease requiring systemic therapy
  • Use of systemic steroids or immunosuppression at time of cell infusion or collection, or conditions likely to require such therapy during these times
  • Progressive central nervous system disease or CNS parenchymal lesions increasing CNS toxicity risk
  • Pregnant or nursing women
  • Uncontrolled active infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

Loading map...

Research Team

C

CART Nurse Navigator

CONTACT

M

Melissa S. Varghese, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here