Combining two CAR T cell therapies for treating advanced B-ALL in children

Use of Autologous Anti-CD22 CAR T Cells (CART22-65s) Co-administered With Humanized Anti-CD19 CAR T Cells (huCART19) in Children and Young Adults With Relapsed or Refractory B-ALL

This study is testing if giving two types of CAR T cell therapies together can help children and young adults with advanced B-cell leukemia who haven't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: N/A to 29 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (Academic / other)
• Drugs / interventions: CAR T, CART
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05674175 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of co-administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B-cell Acute Lymphoblastic Leukemia (B-ALL). The approach aims to address the common issue of disease relapse by targeting both CD19 and CD22 antigens, which are often involved in treatment failure. By utilizing next-generation CAR T cell therapies, the study seeks to enhance patient outcomes for those who have not responded to previous treatments. The trial will include patients aged 0-29 years with documented CD19+ and/or CD22+ disease.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 0-29 years with relapsed or refractory B-ALL or those with poor responses to prior B cell-directed therapies.

Not a fit: Patients without documented CD19+ and/or CD22+ disease or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce relapse in pediatric patients with advanced B-ALL.

How similar studies have performed: Other studies have shown promise with CAR T cell therapies, but this specific combination approach is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent form
2. Patients with documented CD19+ and/or CD22+ ALL/LLy:

   1. Cohort A: Patients with relapsed or refractory ALL/LLy:
   2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
4. 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.
5. Age 0-29 years
6. Adequate organ function
7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
8. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion Criteria:

1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
4. 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.
5. 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.
6. Pregnant or nursing (lactating) women
7. Uncontrolled active infection

Where this trial is running

Philadelphia, Pennsylvania

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

Study contacts

• Principal investigator: Regina Myers, MD — Children's Hospital of Philadelphia
• Study coordinator: CART Nurse Navigator

Conditions B-cell Acute Lymphoblastic Leukemia; B Lineage Lymphoblastic Lymphoma