RECRUITING

Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)

Conditions

B Cell Acute Lymphoblastic Leukemia (B-ALL)B Lineage Lymphoblastic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).

Official Title

Phase 1/2b Trial of Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells Manufactured Using the CliniMACS Prodigy Platform for the Treatment of Pediatric B Cell Acute Lymphoblastic Leukemia (B-ALL)

Quick Facts

Study Start:2022-09-20

Study Completion:2029-09-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05480449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 29 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed Informed Informed Consent 2. Subjects with documented CD19+ ALL or Lly: 1. Cohort A: Subjects with relapsed or refractory ALL or Lly 2. Cohort B: Subjects with poor response to prior B cell directed engineered cell therapy, 3. Subjects with prior or current history of CNS3 disease will be eligible if Central Nervous System (CNS) disease is responsive to therapy (at infusion, must meet criteria in Section 7.6.2). 4. Documentation of CD19 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry. If the subject has received CD19-directed therapy, flow cytometry should be obtained after this therapy to demonstrate CD19 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.	1. Active hepatitis B or active hepatitis C 2. HIV infection 3. Active acute or chronic graft-versus-host disease (GVHD) 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. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 6. Pregnant or nursing (lactating) women. 7. Uncontrolled active infection. 8. History of seizure disorder that requires ongoing anti-epileptic therapy. 9. If the subject has received previous CAR T cell therapies, history of grade 3 or higher ICANS following administration of a CAR T cell product.

Inclusion Criteria

Exclusion Criteria

1. Signed Informed Informed Consent
2. Subjects with documented CD19+ ALL or Lly:
1. Cohort A: Subjects with relapsed or refractory ALL or Lly
2. Cohort B: Subjects with poor response to prior B cell directed engineered cell therapy,
3. Subjects with prior or current history of CNS3 disease will be eligible if Central Nervous System (CNS) disease is responsive to therapy (at infusion, must meet criteria in Section 7.6.2).
4. Documentation of CD19 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry. If the subject has received CD19-directed therapy, flow cytometry should be obtained after this therapy to demonstrate CD19 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.

1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic graft-versus-host disease (GVHD) 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. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
6. Pregnant or nursing (lactating) women.
7. Uncontrolled active infection.
8. History of seizure disorder that requires ongoing anti-epileptic therapy.
9. If the subject has received previous CAR T cell therapies, history of grade 3 or higher ICANS following administration of a CAR T cell product.

Contacts and Locations

Study Contact

Raabia Khan, MPH

CONTACT

2674264947

khanr@chop.edu

Principal Investigator

Allison Barz Leahy, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Stephan Grupp, MD,PhD

STUDY_DIRECTOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Stephan Grupp MD PhD

Allison Barz Leahy, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
Stephan Grupp, MD,PhD, STUDY_DIRECTOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-20

Study Completion Date2029-09-20

Study Record Updates

Study Start Date2022-09-20

Study Completion Date2029-09-20

Terms related to this study

Additional Relevant MeSH Terms

B Cell Acute Lymphoblastic Leukemia (B-ALL)
B Lineage Lymphoblastic Lymphoma