A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)

Conditions

• Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
• Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

0 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• AUTO1 — BIOLOGICAL
  Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells

Study Details

This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).

Key Dates

Start date

Nov 16, 2023

Status verified

Feb 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: AUTO1

Primary Outcome Measure

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 24 months ]

Central Contacts

• Autolus Ltd
  +44 (0) 203 911 4385
  [email protected]

Locations (3)

Find similar trials in Philadelphia, PA