Orphan Indications for CD19 Redirected Autologous T Cells

Conditions

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

Eligibility Criteria

Sex

ALL

Age

0 Years - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Murine CART19 — BIOLOGICAL
  CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection with a planned dose of 5x106 CART19 cells/kg on day 0 with possible reinfusion/retreatment

Study Details

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).

Key Dates

Start date

Mar 12, 2020

Status verified

Mar 2026

Primary completion

Mar 10, 2028

Completion

Mar 10, 2037

Study Design

Enrollment

133 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Subjects with hypodiploid B-ALL
• Experimental: Subjects with t(17;19) B-ALL
• Experimental: Infant subjects with very high risk KMT2A B-ALL
• Experimental: Subjects with central nervous system (CNS) relapse
  who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT)

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: One year ]

Central Contacts

• CART Nurse Navigator
  445-942-5891
  [email protected]
• Melissa S Varghese, M.S.
  845-553-5358
  [email protected]

Locations (1)

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