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CAR T-cell Therapy

Immunotherapy for Lymphoma

Phase 1 & 2
Waitlist Available
Led By Nathan Schloemer, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will see if a new immunotherapy is safe and effective. It uses a patient's own T-cells that are armed with a CD30 antibody.

Who is the study for?
This trial is for people aged 12-39 with certain CD30+ cancers like lymphoma and leukemia, who have measurable disease and no effective standard treatments left. They must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and haven't had some other cancer in the last 5 years.Check my eligibility
What is being tested?
The trial tests a new immunotherapy using patients' own T-cells armed with a special CD30 antibody against their cancer. It's the first time this treatment is being tried on humans to see if it's safe and works.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical immune-related reactions such as fever, fatigue, allergic responses to the therapy components, or worsening of underlying conditions due to immune system activation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Define Toxicities - CTCAE v5.0
Maximum Tolerated Dose
Secondary outcome measures
Define anti-tumor activity - Objective Response Rate
Antineoplastic Agents
In vitro activity - quantitative cytotoxicity
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD30biAb-AATCExperimental Treatment1 Intervention
Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF in 4-week cycles for a maximum of two total cycles.

Find a Location

Who is running the clinical trial?

Midwest Athletes Against Childhood CancerUNKNOWN
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,559 Total Patients Enrolled
28 Trials studying Leukemia
5,200 Patients Enrolled for Leukemia
Nathan Schloemer, MDPrincipal InvestigatorMedical College of Wisconsin / Children's Wisconsin

Media Library

CD30 biAb-AATC (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05544968 — Phase 1 & 2
Leukemia Research Study Groups: CD30biAb-AATC
CD30 biAb-AATC (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544968 — Phase 1 & 2
Leukemia Clinical Trial 2023: CD30 biAb-AATC Highlights & Side Effects. Trial Name: NCT05544968 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers still being accepted for this experiment?

"Data from clinicaltrials.gov suggests that this particular trial is not currently looking for new patients to enroll. This information is accurate as of September 14th, 2022 and was last updated on December 1st, 2022. There are 3,592 other trials that are still recruiting individuals however."

Answered by AI

Does this research require subjects to be under a certain age?

"For this particular study, we are only looking for young adults aged 1 year to 39 years old. Out of the 3043 studies involving patients over 65, 852 specifically target those under 18 years old."

Answered by AI

What are the main goals that researchers hope to achieve with this clinical trial?

"The primary objective of this long-term study is to track and document the adverse effects of the CD30 biAb-AATC drug via CTCAE v5.0. Additionally, researchers will be measuring patient reported outcomes like PROMIS 29 Profile Version 2.1 for adults and PROMIS Pediatric 25 Profile Version 2.0 for children ages 5 to 7 (caregiver proxy) and 8 to 17 (self-report), as well as Pharmacokinetics of CD30 biAb-AATC - AUC(0-28day)."

Answered by AI

Are people with pre-existing conditions able to join the trial?

"This clinical trial is looking for 42 patients with cd30+ anaplastic large cell lymphoma. Eligible participants must be aged 1 year or older, and must have histologic or cytologic verification of a qualified malignancy at original diagnosis. Additionally, patients must have CD30 expression status on malignant cells, as well as measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria from the NCI for assessment of radiographic response. Lastly, eligible participants must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy"

Answered by AI

Who else is applying?

What state do they live in?
Washington
Arizona
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
CD30biAb-AATC for CD30+ Malignancies
Nathan J Schloemer 2024. "CD30biAb-AATC for CD30+ Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544968.
All > Hodgkin Lymphoma > Leukemia
~28 spots leftby Jan 2027
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