Orphan Indications for CD19 Redirected Autologous T Cells

Description

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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

Orphan Indications for CD19 Redirected Autologous T Cells

Condition
Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Signed informed consent form must be obtained prior to any study procedure.
  • 2. Male and female patients with documented CD19+ B-ALL
  • 3. Expression of CD19 on leukemic blasts demonstrated by flow cytometry of bone marrow, cerebrospinal fluid, or peripheral blood
  • 4. Age 0 to 29 years
  • 5. Adequate organ function defined as:
  • 1. A serum creatinine based on age/gender as follows:
  • 2. Adequate liver function:
  • 6. Adequate performance status defined as Lansky or Karnofsky score ≥ 50
  • 7. Subjects of reproductive potential must agree to use acceptable birth control methods
  • 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.

Ages Eligible for Study

0 Years to 29 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stephan Grupp MD PhD,

Stephan Grupp, MD, PhD, STUDY_DIRECTOR, Children's Hospital of Philadelphia

Study Record Dates

2037-03-10