Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients With CD19-Positive Relapsed/ Refractory (r/r) B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL)
This is a Phase Ib study to evaluate the safety and 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 relapsed or refractory B cell Non-Hodgkin lymphoma (B NHL)
Status | Recruiting |
Enrollment | 24 |
Est. completion date | November 2027 |
Est. primary completion date | November 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 18 Years |
Eligibility | Inclusion Criteria: - Male or female patients < 18 years old at screening - Patients with = 6 kg body weight at screening - B ALL Cohort: r/r CD19-positive B ALL defined as: - Primary refractory disease defined as: - Children's Oncology Group (COG) very high risk first relapse if first remission =18 months. - Relapsed or refractory disease after two or more lines of systemic therapy. - Relapsed or refractory disease after allogeneic transplant provided AUTO1 infusion occurs at least 3 months after stem cell transplant.. - Any of the above with Philadelphia chromosome positive disease (Ph+ ALL) where patient is intolerant to or has failed two lines of any tyrosine kinase inhibitor (TKI) or one line of second-generation TKI, or if TKI therapy is contraindicated - B NHL Cohort: r/r CD19-positive aggressive mature B NHL defined as: - Relapsed after one or more prior therapies (can include allogeneic and autologous hematopoietic stem cell transplant) - Primary refractory (have not achieved a complete or partial response after the first line of therapy) with measurable, biopsy-proven disease by radiological criteria at screening including the B NHL subtypes diffuse large B-cell lymphoma (DLBCL), Burkitt's lymphoma, primary mediastinal large B-cell lymphoma (PMBCL) and high-grade B-cell lymphoma (not otherwise specified) - Karnofsky (age = 10 years) or Lansky (age < 10 year) performance status score = 50%. - Local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid (CSF) or biopsy within 30 days of consent - Adequate renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: - Diagnosis of chronic myelogenous leukemia lymphoid in blast crisis - History or presence of clinically relevant central nervous system (CNS) pathology - Presence of CNS 3 disease or CNS 2 disease with neurological changes at screening - Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management - Patients who had prior (less than 3 months before AUTO 1 infusion) stem cell transplant - Prior CD19 targeted therapy other than blinatumomab - Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital for Children NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Autolus Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of adverse events (AE) and serious adverse events (SAE) | Up to 24 months | ||
Primary | Incidence of severe hypogammaglobulinemia | Up to 24 months | ||
Primary | Duration of severe hypogammaglobulinemia | Up to 24 months | ||
Secondary | Overall remission rate in B ALL patients | Defined as best response of complete remission or complete remission with incomplete recovery of counts per Investigator assessment occurring at any time after AUTO1 infusion | Up to 24 months | |
Secondary | Overall response rate in B NHL patients | Defined as best response of complete response or partial response per Investigator assessment occurring at any time after AUTO1 infusion | Up to 24 months | |
Secondary | Duration of remission in B ALL | Up to 24 months | ||
Secondary | Duration of response in B NHL | Up to 24 months | ||
Secondary | Overall survival in B ALL | Up to 24 months | ||
Secondary | Overall survival in B NHL | Up to 24 months | ||
Secondary | Incidence of CD19-negative relapse at any time in B ALL | Up to 24 months | ||
Secondary | Incidence of CD19-negative relapse at any time in B NHL | Up to 24 months | ||
Secondary | Event-free survival in B ALL | Up to 24 months | ||
Secondary | Proportion of patients achieving minimal residual disease (MRD)-negative remission in BM within 3 months of AUTO1 dosing in B ALL | Up to 24 months | ||
Secondary | Proportion of patients achieving complete remission within 3 months per Investigator assessment in B ALL | Up to 24 months | ||
Secondary | Progression-free survival in B NHL | Up to 24 months |
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