BridgeMD
New treatment option for Hodgkin Disease
Official title Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
ClinicalTrials.gov ID: NCT05544968
What this study is testing
What is anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC)?
anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hodgkin disease.
Also referred to as CD30 biAb-AATC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis: Patients must have had histologic or cytologic verification of the below qualified malignancy. The pathology report for the diagnosis...
- Direct Bilirubin \<1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) the...
- SGPT (ALT) \<3 x ULN.
- Serum albumin \>2 g/dL. iii. Pulmonary: Pulse oximetry \>90% on room air. people must have no supplemental oxygen requirement. iv. Cardiac: LVEF ≥...
- Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 7 days prior to enrollment.
You likely can't join if
- Prior Therapy: Any toxicities from prior treatment, \>Grade 3 per CTCAE v5.0 Hematopoietic stem cell transplantation (HCT) or chimeric antigen...
- Investigational Agent: Treatment with any investigational agent within 14 days of enrollment.
- Exclusion Requirements Due to Comorbid Disease or Concurrent Illness:
- Immune: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7...
- Infectious: Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the...
- Pulmonary: Prior history of anti-CD30 therapy related pulmonary toxicity.
See the full eligibility criteria
- Diagnosis: Patients must have had histologic or cytologic verification of the below qualified malignancy. The pathology report for the diagnosis under which the patient is being enrolled and associated molecular...
- Direct Bilirubin \<1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) the bilirubin must be ≤3 x ULN for age.
- SGPT (ALT) \<3 x ULN.
- Serum albumin \>2 g/dL. iii. Pulmonary: Pulse oximetry \>90% on room air. people must have no supplemental oxygen requirement. iv. Cardiac: LVEF ≥ 40% by ECHO or MUGA. v. HL and NHL specific criteria: Bone Marrow...
- Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 7 days prior to enrollment.
- Female patients must meet one of the following: i. Postmenopausal for at least one year before the screening visit, or ii. Surgically sterile, or iii. If they are of childbearing potential, agree to practice a reliable...
- Prior Therapy: Any toxicities from prior treatment, \>Grade 3 per CTCAE v5.0 Hematopoietic stem cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CAR-T cell) within 60 days of enrollment, or...
- Investigational Agent: Treatment with any investigational agent within 14 days of enrollment.
- Exclusion Requirements Due to Comorbid Disease or Concurrent Illness:
- Immune: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication...
- Infectious: Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other...
- Pulmonary: Prior history of anti-CD30 therapy related pulmonary toxicity.
- Neurologic: Prior history of progressive multifocal leukoencephalopathy (PML).
- Cardiac: Patients diagnosed with NYHA Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled hypertension.
- Allergies: Known hypersensitivity or allergic reaction attributed to any of the components of CD30 biAb-AATC or to compounds of similar composition to CD30 targeted agent, or a bispecific Antibody-armed activated...
- Pregnant or Breastfeeding: Pregnant or breastfeeding females will not be allowed to enroll on this study. Female patients with infants must agree not to breastfeed their infants during the entire study treatment period...
- Secondary Malignancy: Patients should not have a history of any second malignancy in the last 1 year with exception of the diagnosis for inclusion; people with prior history of in situ cancer or basal or squamous cell...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, 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 ClinicalTrials.gov; the study team decides eligibility.