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Orphan Indications for CD19 Redirected Autologous T Cells | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Orphan Indications for CD19 Redirected Autologous T Cells

CD19-Directed Chimeric Antigen Receptor CD19 Redirected Autologous T Cells (CART19) for Orphan Indications of Pediatric B Cell Acute Lymphoblastic Leukemia (B ALL)

NCT04276870•Stephan Grupp MD PhD

View on ClinicalTrials.gov

Summary

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).

Eligibility

Age

0 - 29 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent form must be obtained prior to any study procedure.
•2. Male and female patients with documented CD19+ B-ALL
•a.Cohort A \& B: Patients, regardless their response to initial or relapsed B ALL therapy, with the following characteristics: i.Cohort A: Subjects with confirmation of a hypodiploid karyotype (chromosome number fewer than 45) ii.Cohort B: Subjects with cytogenetic confirmation of the chromosomal translocation t(17;19) (Cohort B) b.Cohort C: Infants w/ newly diagnosed KMT2A rearranged B-ALL classified as very high risk by the following criteria: i.Age \< 3 months at diagnosis ii.Age \< 6 months and WBC \> 300,000x109/L at diagnosis or a poor prednisone response in induction iii.MRD positive \> 0.01 (or PCR \> 104) after 2 courses of standard infant ALL therapy.
•c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with cranial XRT or HSCT for the current relapse
•3. Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue.
•4. Age 0 to 29 years
•5. Adequate organ function defined as:
•1. A serum creatinine based on age/gender as follows:
•Maximum Serum Creatinine (mg/dL) Age Male Female 0 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1.0 1.0 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
•≥ 16 years 1.7 1.4
+6 more criteria

Exclusion Criteria

•1. For subjects with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion.
•2. Active hepatitis B or active hepatitis C.
•3. HIV Infection.
•4. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
•5. Concurrent use of systemic steroids 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 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.
•6. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
•7. Pregnant or nursing (lactating) women.
•8. Uncontrolled active infection.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 12, 2020

Primary Completion Date

March 10, 2028

Completion Date

March 10, 2037

Last Updated

March 6, 2026

Enrollment

133

ESTIMATED participants

Conditions

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALLInfants With Very High Risk KMT2A B-ALLPatients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation

Interventions

Murine CART19

BIOLOGICAL

Contacts

CART Nurse Navigator

CONTACT

445-942-5891 CARTNurseNavigator@chop.edu

Melissa S Varghese, M.S.

CONTACT

845-553-5358 varghesem@chop.edu