BridgeMD
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)
EU CTIS ID: 2023-506307-26-00
What this study is testing
B ALL Cohort: To demonstrate the clinical efficacy of obe-cel treatment regimen in pediatric participants with r/r B ALL. B ALL and B NHL Cohorts: To evaluate the safety and tolerability of obe-cel in pediatric participants with B ALL and B NHL.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females < 18 years old at screening
- ≥ 6 kg body weight at screening
- Willing and able to give written, informed consent to the current study (participant and/or parent or legal guardian).
- Agreement to have a pregnancy test and use adequate contraception (if applicable).
- Participants with a diagnosis of r/r CD19-positive B ALL defined as one of the following sub-categories: (1) Primary refractory (2) First relapse (3) Second or greater relapse (4) Relapsed or refractory disease post-allogeneic stem cell transplant (5) Philadelphia chromosome-positive (Ph+) ALL. All B ALL participants enrolled during the Phase 2 portion of the study must meet a disease status, documented at screening per NCCN Guidelines: Pediatric ALL definitions for r/r pediatric B ALL
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance score ≥ 50.
You likely can't join if
- Chronic myelogenous leukemia lymphoid in blast crisis.
- History or presence of clinically relevant CNS pathology
- Active CNS involvement by malignancy, defined as CNS-3 per pediatric NCCN Guidelines. Note: Individuals with a history of CNS disease that has been effectively treated to CNS1 or CNS2 status at the time of enrollment will be eligible
- Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
- History or presence of active or latent Hepatitis B virus or active Hepatitis C virus.
- History of human immunodeficiency virus (HIV), human T cell lymphotropic virus (HTLV)-1, HTLV-2, or syphilis positive test.
See the full eligibility criteria
- Males or females < 18 years old at screening
- ≥ 6 kg body weight at screening
- Willing and able to give written, informed consent to the current study (participant and/or parent or legal guardian).
- Agreement to have a pregnancy test and use adequate contraception (if applicable).
- Participants with a diagnosis of r/r CD19-positive B ALL defined as one of the following sub-categories: (1) Primary refractory (2) First relapse (3) Second or greater relapse (4) Relapsed or refractory disease post-allogeneic stem cell transplant (5) Philadelphia chromosome-positive (Ph+) ALL. All B ALL participants enrolled during the Phase 2 portion of the study must meet a disease status, documented at screening per NCCN Guidelines: Pediatric ALL definitions for r/r pediatric B ALL
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance score ≥ 50.
- For individuals with B ALL, documentation of CD19 expression on leukemic blasts in the BM, peripheral blood or cerebrospinal fluid (CSF), or biopsy no more than 30 days prior to consent. In participants treated with blinatumomab, testing should be undertaken after blinatumomab therapy has been stopped. In participants with mature B NHL, CD19 expression must be confirmed in a biopsy after any CD19-targeting therapies.
- Chronic myelogenous leukemia lymphoid in blast crisis.
- History or presence of clinically relevant CNS pathology
- Active CNS involvement by malignancy, defined as CNS-3 per pediatric NCCN Guidelines. Note: Individuals with a history of CNS disease that has been effectively treated to CNS1 or CNS2 status at the time of enrollment will be eligible
- Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
- History or presence of active or latent Hepatitis B virus or active Hepatitis C virus.
- History of human immunodeficiency virus (HIV), human T cell lymphotropic virus (HTLV)-1, HTLV-2, or syphilis positive test.
- Prior CD19 targeted therapy other than blinatumomab.
- Patients who have experienced ≥ Grade 3 neurotoxicity following blinatumomab.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.