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CAR T-cell Therapy
Engineered T-Cell Therapy for Cancer
Phase 1 & 2
Waitlist Available
Led By Scott Kopetz, MD, PhD
Research Sponsored by Ziopharm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have evaluable or measurable disease per RECIST 1.1 with at least one lesion that can be measured that is not the biopsied lesion
Patients who have completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002) and for whom a TCR(s) matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' Clinical TCR library
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new way to treat cancer using a person's own T cells that have been engineered to be more effective against the cancer.
Who is the study for?
Adults with certain solid tumors like lung, ovarian, colorectal, pancreatic cancer who've tried at least one treatment without success. They must be in fairly good health otherwise (ECOG 0 or 1), have a tumor that can be measured and not currently pregnant or breastfeeding. Excluded are those with bleeding disorders, compromised immune systems, severe mental illness affecting study compliance, active brain metastases, recent major heart issues or other serious medical conditions.Check my eligibility
What is being tested?
The trial is testing T cells modified to target specific cancer cell markers using Sleeping Beauty transposon/transposase system alongside Aldesleukin (IL-2). It's for patients whose cancers haven't responded to standard treatments and involves multiple phases to assess safety and effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs. There might also be typical symptoms associated with immunotherapies such as fatigue, feverish feelings or chills due to the activation of the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cancer lesion that can be measured, separate from the one biopsied.
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I have completed specific genetic tests and there is a matching treatment in the clinical library.
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I am 18 years old or older.
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My condition is pancreatic cancer.
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I am not pregnant or breastfeeding.
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I have ovarian cancer.
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I have endometrial cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: To define the incidence of dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of T-Cell Receptor T cells
Phase II: Incidence of Adverse Events as characterized by type, frequency, severity (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy.
Phase II: Objective response rate (ORR) evaluated by Investigator assessments using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Secondary outcome measures
Phase I: To evaluate the feasibility of neoantigen-specific T-Cell Receptor T cells (herein referred to as TCR-T cells) manufacturing.
Phase I: To investigate translational hypotheses related to TCR-T cell persistence without IL-2 (Arm A) or with IL-2 (Arm B).
Phase II: To confirm Phase I results of translational hypotheses related to TCR-T cell persistence without IL-2 (Arm A) or with IL-2 (Arm B).
Other outcome measures
Phase I: To evaluate the objective response rate (ORR) (RECIST and iRECIST criteria) of subjects with solid cancers who receive TCR-T cell drug product.
Phase I: To explore translational hypotheses related to molecular signatures, mechanism of action, immunogenicity, and serum cytokine profiles associated with TCR-T cell drug product infusion without IL-2 (Arm A) or with IL-2 (Arm B).
Phase II: To evaluate anti-tumor activity (ORR) (iRECIST) of TCR-T cell drug product without IL-2 (Arm A) or with IL-2 (Arm B) in each of the tumor types.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: TCR-T Cell Drug Product with Aldesleukin (IL-2)Experimental Treatment2 Interventions
Phase I: Dose-escalation of TCR-T Cell Drug Product with Aldesleukin (IL-2)
Phase II: Single dose of TCR-T Cell Drug Product with Aldesleukin (IL-2) after MTD/RP2D determine in Phase I portion of the study
Group II: TCR-T Cell Drug ProductExperimental Treatment1 Intervention
Phase I: Dose-escalation of TCR-T Cell Drug Product
Phase II: Single dose of TCR-T Cell Drug Product after MTD/RP2D determine in Phase I portion of the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Find a Location
Who is running the clinical trial?
ZiopharmLead Sponsor
35 Previous Clinical Trials
3,823 Total Patients Enrolled
Alaunos TherapeuticsLead Sponsor
40 Previous Clinical Trials
4,219 Total Patients Enrolled
Scott Kopetz, MD, PhDPrincipal InvestigatorMD Anderson
1 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My major organs are functioning well.I have a cancer lesion that can be measured, separate from the one biopsied.You have a condition that weakens your immune system from birth.I do not have any unstable or significant health conditions.I have a severe long-term lung problem.I am mostly active and can care for myself without needing approval for a slightly reduced activity level.I am currently taking steroid medication.My health history may not allow me to tolerate high-dose aldesleukin.I have advanced cancer and my previous treatment didn't work or caused side effects.I have completed specific genetic tests and there is a matching treatment in the clinical library.I've had minor surgery or targeted radiotherapy and have recovered from major side effects.I am 18 years old or older.I have recovered from previous cancer treatments, except for nerve issues or hair loss.My condition is pancreatic cancer.I have not had any major heart problems in the last 6 months.I do not have any active, uncontrolled infections.I am not pregnant or breastfeeding.I have a major blockage or bleeding in my airways that can't be relieved.I have a history of bleeding disorders or unexplained severe bleeding.I have ovarian cancer.My immune system is weaker than normal.I have colorectal cancer.I have active cancer spread to my brain.I can sign and understand the consent form.I have endometrial cancer.Your blood and bone marrow need to be healthy, as checked by specific blood tests.I have or had another type of cancer.You had a serious allergic reaction to certain medications in the past.
Research Study Groups:
This trial has the following groups:- Group 1: TCR-T Cell Drug Product
- Group 2: TCR-T Cell Drug Product with Aldesleukin (IL-2)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Squamous Cell Carcinoma Patient Testimony for trial: Trial Name: NCT05194735 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this trial?
"The clinical trial, which initially went online on April 4th of 2022 and underwent the latest revision on July 27th of the same year, is actively seeking volunteers."
Answered by AI
Is the minimum age of participants in this clinical inquiry restricted to those under 50?
"Eligibility for this trial is limited to individuals aged 18 and below 75."
Answered by AI
What is the aggregate quantity of individuals participating in this medical study?
"Affirmative. According to the clinicaltrials.gov website, this medical trial is currently open for recruitment and seeks 180 individuals from a single location. This study was initially posted on April 4th 2022 and last updated on July 27th 2022."
Answered by AI
Do I meet the criteria to participate in this medical research?
"This clinical trial is recruiting 180 adults aged 18 to 75 with adenocarcinoma of lung, who also meet the following criteria: Having completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002) for which a valid TCR matching their somatic mutation and HLA type restriction combination exists in Alaunos' Clinical TCR library; having ovarian cancer, endometrial cancer, subgroup 2 colorectal cancer, subgroup 3 pancreatic cancer; non-small cell lung cancer (NSCLC), or cholangiocarcinoma; possessing measurable disease"
Answered by AI
What is the main goal of this medical experiment?
"This medical trial will measure its primary outcome, safety and tolerance of the cell transfer using CTCAE v5.0 over a two year period. Secondary outcomes include Best Overall Response (based on investigator assessment), Duration of Objective Response (length between first documented response to progression or subsequent therapy) and Progression-Free Survival (time from infusion to progression or death)."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
British Columbia
What site did they apply to?
MD Anderson Cancer Center
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
How long do I have to spent in Houston for the trial?
PatientReceived no prior treatments
Why did patients apply to this trial?
I've tried chemotherapy Gemcitabine + cisplatin and immunotherapy durvalumab and didn't work.
PatientReceived 2+ prior treatments
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