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CAR T-cell Therapy
Activated T Cells for Brain Cancer
Phase 1
Waitlist Available
Led By Jeremy Rudnick, MD
Research Sponsored by Jeremy Rudnick, M.D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent glioblastoma
HLA-A1 and HLA-A2 positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline visit and at time of recurrence. assessed up to 3 years.
Awards & highlights
Study Summary
This trial is testing if ATCs are safe and tolerable in people with cancer, and if they help with survival or quality of life.
Who is the study for?
This trial is for individuals with recurrent glioblastoma who are HLA-A1 and HLA-A2 positive and have had a complete resection of their tumor. It's not suitable for those with HIV/AIDS, hepatitis B or C, allergies to DMSO or gentamicin, significant heart or lung disease, or active infections needing treatment.Check my eligibility
What is being tested?
The study tests the safety and tolerability of autologous activated T cells (ATCs) in patients with recurrent glioblastoma. It aims to find the maximum tolerated dose while monitoring serious adverse events and treatment-related toxicities using NCI CTCAE V5 criteria.See study design
What are the potential side effects?
Potential side effects include Grade 3 or higher toxicities such as severe immune reactions, infusion-related complications, and possible worsening of underlying conditions due to ATC therapy as per NCI CTCAE Version 5 guidelines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain cancer has come back after treatment.
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I am HLA-A1 and HLA-A2 positive.
Select...
My tumor has been completely removed surgically.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline visit and at time of recurrence. assessed up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline visit and at time of recurrence. assessed up to 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose
Secondary outcome measures
Health-related quality of life parameters
Immune Response
Overall Response Rate (ORR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Activated T cellsExperimental Treatment1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy with temozolomide. These treatments aim to remove or reduce the tumor and kill cancer cells.
Recently, immunotherapy, such as the use of autologous activated T cells, has gained attention. This approach involves enhancing the patient's immune system to recognize and attack cancer cells more effectively.
For Glioblastoma patients, this is crucial as it offers a targeted method to combat the tumor, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
Irradiation to Improve the Response to Immunotherapeutic Agents in Glioblastomas.
Irradiation to Improve the Response to Immunotherapeutic Agents in Glioblastomas.
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Who is running the clinical trial?
Jeremy Rudnick, M.DLead Sponsor
Kairos PharmaUNKNOWN
Jeremy Rudnick, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently being treated for an infection, but I may be taking preventive medication.I have a history of Hepatitis B or C.My brain cancer has come back after treatment.I am HLA-A1 and HLA-A2 positive.I have a serious lung, heart, or other major health issue.I have HIV/AIDS or another serious health condition.My tumor has been completely removed surgically.
Research Study Groups:
This trial has the following groups:- Group 1: Activated T cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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