CD19 targeted CAR T cell therapy for children with relapsed or refractory B cell leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib study evaluates the safety and preliminary efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in pediatric patients with relapsed or refractory B cell acute lymphoblastic leukemia (B ALL) and aggressive mature B-cell non-Hodgkin lymphoma (B NHL). The study is single-arm and open-label, involving sequential periods of screening, leukapheresis, lymphodepletion, treatment evaluation, and follow-up. Safety data will be monitored continuously, with an Independent Data Monitoring Committee reviewing the data after specific patient milestones.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Lucile Packard Children's Hospital, Stanford University
  Palo Alto, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Lurie Children's Hospital
  Chicago, Illinois, United States Recruiting
• Cincinnati Children's Hospital
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Autolus Ltd
• Email: clinicaltrials@autolus.com
• Phone: +44 (0) 203 911 4385

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GN001 therapy for B-cell cancers that have come back or not responding

  This study tests GN001, a CAR T therapy created inside the body, in adults with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia to see if it is safe and tolerable at different doses.

  Recruiting at 2 sites Phase 1 Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital · Kunming, Yunnan and 1 other locations · NCT07910708

• Evaluating B019 Injection for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

  This study is testing a new injection called B019 to see if it can help people with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia feel better.

  Recruiting at 8 sites Phase 1 Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. · Beijing and 7 other locations · NCT06927466

• Evaluating YK012 for treating relapsed or refractory B-cell non-Hodgkin lymphoma

  This study is testing a new drug called YK012 to see if it can safely help people with relapsed or refractory B-cell non-Hodgkin lymphoma.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06565689

• Evaluating a new treatment for relapsed or refractory B-Cell Non-Hodgkin Lymphoma

  This study is testing a new immunotherapy called MK-1045 to see if it can safely help people with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.

  Recruiting at 13 sites Phase 1 MSD R&D (China) Co., Ltd. · Beijing, Beijing Municipality and 14 other locations · NCT06189391

• Effects of CART19 Cells in Patients with Certain Blood Cancers

  This study is testing a new treatment using modified immune cells to see if it can help adults with certain types of blood cancers that haven't responded to other therapies.

  Recruiting Phase 1 Institute of Hematology and Blood Transfusion, Czech Republic · Prague · NCT05054257

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.