MAGE-A4ᶜ¹º³²T Therapy for Cancer

Not currently recruiting at 12 trial locations
DH
Overseen ByDavid Hong, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Adaptimmune
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MAGE-A4ᶜ¹º³²T, which uses specially modified T cells to target certain cancers, including bladder, melanoma, and lung cancer. The goal is to determine the treatment's safety and how the body tolerates it. Eligible participants will have T cells taken from their body, modified to attack cancer, and then reintroduced. Additionally, a small group will receive the treatment combined with low-dose radiation to assess its impact on safety. This trial suits individuals whose tumors display a specific protein and who have a certain tissue marker. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that subjects receiving excluded therapy or treatment per protocol are not eligible, which might imply some medications could be restricted. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the MAGE-A4ᶜ¹º³²T cell therapy has been tested in people with various types of cancer, such as bladder, melanoma, and lung cancer. The main goal was to determine the treatment's safety and patient tolerance. So far, results suggest that the therapy is generally well-tolerated, with most people not experiencing severe side effects.

Common side effects reported include tiredness and fever, but these were manageable and temporary. The treatment remains in the early stages of testing, so researchers are primarily focusing on safety. They closely monitor patients and make adjustments as needed to ensure safety.

For those considering joining a trial, it is reassuring to know that this therapy undergoes careful testing. If the treatment were dangerous, it would not be allowed to continue. Discussing any concerns with the trial team can help answer questions about what to expect.12345

Why are researchers excited about this trial's treatments?

Unlike the standard of care for cancer, which often includes chemotherapy and radiation, MAGE-A4ᶜ¹º³²T therapy is unique because it uses autologous genetically modified T cells. These T cells are engineered to specifically target the MAGE-A4 protein, which is present in certain tumors but not in normal tissues, offering a more precise attack on cancer cells. Researchers are excited about this approach because it promises to minimize damage to healthy cells and could lead to more effective and personalized cancer treatments. Additionally, the inclusion of a radiation sub-study with MAGE-A4c1 aims to enhance the therapy's effectiveness by potentially increasing the cancer-killing capabilities of the modified T cells.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that MAGE-A4ᶜ¹º³²T cell therapy could be effective against certain cancers. In previous studies, patients with tumors producing the MAGE-A4 protein responded well to this treatment, with about 43% experiencing a reduction or disappearance of their tumors. These specially engineered T cells are designed to find and destroy cancer cells, which may explain their success. In this trial, some participants will receive MAGE-A4ᶜ¹º³²T cells alone, while others will receive them combined with low-dose radiation. Early results suggest that combining MAGE-A4ᶜ¹º³²T cells with low-dose radiation might improve outcomes, but more research is needed to confirm this.13678

Who Is on the Research Team?

David S Hong | MD Anderson Cancer Center

David Hong, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with certain cancers (like sarcoma, melanoma, and lung cancer) that express the MAGE-A4 protein and are HLA-A*02 positive. They should have measurable disease, adequate organ function, a life expectancy over 6 months, and no active infections like HIV or hepatitis.

Inclusion Criteria

You are expected to live for at least 6 months before a certain procedure and 3 months before another procedure.
My tumor tests positive for MAGE-A4.
I am HLA-A*02 positive.
See 4 more

Exclusion Criteria

Subject is pregnant or breastfeeding.
I have no other active cancers and no uncontrolled illnesses.
I have symptoms from cancer spreading to my brain.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MAGE-A4ᶜ¹º³²T cell therapy, potentially in combination with low dose radiation

3.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
  • MAGE-A4ᶜ¹º³²T
Trial Overview The study tests MAGE-A4ᶜ¹º³²T cell therapy where patients' T cells are modified to attack tumors expressing MAGE-A4. A subgroup will also receive these T cells plus low-dose radiation to assess safety and effectiveness of this combination.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1Experimental Treatment1 Intervention
Group II: Autologous genetically modified MAGE-A4ᶜ¹º³²T cellsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adaptimmune

Lead Sponsor

Trials
25
Recruited
10,000+

Published Research Related to This Trial

In a phase II study involving 44 patients with gemcitabine-refractory pancreatic cancer, FOLFOX4 demonstrated an objective response rate of 11.4% and a tumor stabilization rate of 40.9%, indicating its potential efficacy as a rescue therapy.
FOLFOX4 was generally well-tolerated, but significant hematologic toxicities were observed, including grade 3 or 4 neutropenia in 43.2% of patients, highlighting the need for careful monitoring during treatment.
Folfox4 as a rescue chemotherapy for gemcitabine-refractory pancreatic cancer.Chung, JW., Jang, HW., Chung, MJ., et al.[2022]
Immunotherapy shows promise in treating pancreatic cancer by activating T cells to target tumor-specific antigens, which is crucial since conventional therapies have limited effectiveness.
Preclinical studies suggest that combining immunotherapy with chemotherapy or targeted therapy may enhance treatment outcomes, leading to ongoing trials focused on finding effective and less toxic treatment combinations.
Immunotherapy for pancreatic cancer.Kotteas, E., Saif, MW., Syrigos, K.[2023]

Citations

Clinical Trial: NCT03132922This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue ...
MAGE-A4ᶜ¹º³²T Therapy for Cancer · Info for ParticipantsThis study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40423661/
FDA Approval Summary: Afamitresgene Autoleucel for ...Of the 44 efficacy-evaluable patients, the overall response rate was 43.2% (95% confidence interval, 28.4-59.0), with complete response in two ...
Study Title• To evaluate the safety and tolerability of autologous genetically modified T cells (ADP-A2M4) in HLA-A*02 positive subjects with MAGE-A4 expressing advanced ...
Autologous T cell therapy for MAGE-A4+ solid cancers in ...We conducted a multicenter, dose-escalation, phase 1 trial in patients with relapsed/refractory metastatic solid tumors expressing MAGE-A4, ...
Trial | NCT03132922This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose ...
MAGE-A4ᶜ¹º³²T for Multi-Tumor | MedPathThis study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose ...
Initial Safety Assessment of MAGE-A4 Specific Peptide ...• Genetically engineered autologous specific peptide enhanced affinity receptor (SPEAR) T-cells. (MAGE-A4c1032T-cells) directed toward a MAGE-A4 peptide ...
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