Recruiting
Phase 1

CD19 Targeted CAR T

Sponsor:

Autolus Limited

Code:

NCT06173518

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

AUTO1

Study Details

Brief summary:

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).

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Study ID

NCT06173518

Start date

Nov 16, 2023

Status verified date

Feb, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

  • < 18 years old at screening
  • ≥ 6 kg body weight at screening

Pediatric patients with r/r B ALL

r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified).

  • Karnofsky (age ≥ 10 years) or Lansky (age < 10 year) performance status score ≥ 50%.
  • In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.
  • Adequate renal, hepatic, pulmonary, and cardiac function.

EXCLUSION CRITERIA:

  • Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.
  • History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.
  • Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
  • Received prior (< 3 months before obe cel infusion) stem cell transplantation.
  • Prior CD19 targeted therapy other than blinatumomab.
  • Experienced Grade ≥ 3 neurotoxicity following blinatumomab.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AUTO1

Interventions

AUTO1

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

Primary outcome measure

  • Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 24 months ]
  • Incidence and duration of severe hypogammaglobulinemia [ Time Frame: Up to 24 months ]
  • Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Autolus Ltd

+44 (0) 203 911 4385clinicaltrials@autolus.com

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Shannon Maude, MD

Methodist Children's Hospital

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Amanda Lipsitt, MD

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Principal Investigator:

Michael Pulsipher, MD

More Information

Sponsor

Autolus Limited

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • B cell acute lymphoblastic leukemia
  • B cell Non-Hodgkin lymphoma
  • Relapsed B cell acute lymphoblastic leukemia
  • Relapsed B cell Non-Hodgkin lymphoma
  • Refractory B cell acute lymphoblastic leukemia
  • Refractory B cell Non-Hodgkin lymphoma
  • Aggressive mature B cell Non-Hodgkin lymphoma
  • Pediatric ALL
  • Pediatric NHL
  • Obecabtagene autoleucel
  • CD19-positive CAR T cell
  • Obe-cel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Autolus Limited on 2026-03-02.