RightFit
RecruitingPhase 1

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)

A Single-Arm, Open-Label, Multicenter, Phase 1b/2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed/Refractory (R/R) B Cell Acute Lymphoblastic Leukemia (B ALL) or R/R Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CAR T-cell therapy made from a patient’s own immune cells, changed to target a marker called CD19 on cancer cells. It checks safety and how well the treatment works in children with B-cell acute lymphoblastic leukemia (B ALL) or certain aggressive B-cell non-Hodgkin lymphomas (B NHL) that came back or did not respond to treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Younger than 18 years at screening.
  • Weigh at least 6 kg (about 13 pounds) at screening.
  • Have B ALL that came back or did not respond to treatment; or have CD19-positive aggressive B NHL that came back or did not respond to treatment.
  • For B NHL, have one of these types: diffuse large B-cell, Burkitt’s, primary mediastinal large B-cell, or high-grade B-cell lymphoma not otherwise specified.
  • Score at least 50% on an age-based scale that measures ability to do daily activities.
  • For B ALL, have a test showing CD19 on leukemia cells in bone marrow, blood, fluid around the brain and spinal cord, or a tissue sample. The test must be done within 30 days before consent.
  • Have kidneys, liver, lungs, and heart that work well enough.

Who can't join

  • Have chronic myelogenous leukemia in lymphoid blast crisis, a phase with many immature white blood cells.
  • Have or have had a significant brain or spinal cord condition not caused by leukemia.
  • Have an active or uncontrolled infection that needs medicine that works throughout the body.
  • Had a stem cell transplant less than 3 months before the planned CAR T-cell infusion.
  • Previously had treatment targeting CD19, other than blinatumomab.
  • Had severe nervous system side effects (grade 3 or higher) after blinatumomab.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (9)

CA

CO

IL

OH

PA

TX

UT

WA