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

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Acute Lymphoblastic Leukemia, B Lineage Lymphoblastic Lymphoma

In brief

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).

Key facts

Study ID

NCT05674175

Run by

Stephan Grupp MD PhD

People needed

93

Starts

2023-01-25

Expected to finish

2029-07-01

Last updated by the study team

2026-03-27

Who can join

Age: any, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• Patients with documented CD19+ and/or CD22+ ALL/LLy:
• Cohort A: Patients with relapsed or refractory ALL/LLy:
• Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
• Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
• Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and/or CD22 expression.
• Age 0-29 years
• Adequate organ function
• Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
• Subjects of reproductive potential must agree to use acceptable birth control methods.

You may not qualify if…

• Active hepatitis B or active hepatitis C
• HIV infection
• Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
• Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
• Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.
• Pregnant or nursing (lactating) women
• Uncontrolled active infection

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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