Study on HUVR-CARTemis-1 Therapy for Patients with Relapsed Multiple Myeloma After Allogeneic Transplant Using a Drug Combination

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What is this study about?

This clinical trial is focused on studying a treatment for multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The treatment being tested is called HUVR-CARTemis-1, which involves using a patient’s own immune cells, specifically CD4 and CD8 T lymphocytes. These cells are modified in the laboratory to better recognize and attack cancer cells. The purpose of the study is to assess the safety and feasibility of this treatment in patients who have experienced a relapse of multiple myeloma after undergoing an allogeneic transplant, which is a type of bone marrow transplant from a donor.

During the study, participants will receive the HUVR-CARTemis-1 treatment through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor the maximum dose that can be safely given to patients and observe any side effects that may occur. These side effects could include reactions like cytokine release syndrome, which is an immune response that can cause fever and inflammation, or neurological toxicity, which affects the nervous system. The study will also look at how well the treatment works in reducing the cancer and how long the effects last.

In addition to the main treatment, other medications may be used to manage symptoms or side effects. These include fludarabine phosphate, dexchlorpheniramine, tocilizumab, cyclophosphamide, allopurinol, paracetamol, and cetuximab. These medications serve various roles, such as reducing inflammation, managing pain, or supporting the immune system. The study aims to provide valuable information on the potential benefits and risks of using HUVR-CARTemis-1 for treating multiple myeloma, helping to improve future treatment options for patients with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring no immunosuppressants have been taken for at least one month prior.

The patient must have a diagnosis of multiple myeloma relapse after an allogeneic transplant and meet other criteria such as age and life expectancy.

2 pre-treatment phase

Before starting the main treatment, certain medications are administered to prepare the body. These include fludarabine phosphate and cyclophosphamide, both given intravenously.

This phase helps to condition the body for the upcoming therapy.

3 main treatment

The main treatment involves the infusion of HUVR-CARTemis-1 cells. These are specialized cells designed to target and fight multiple myeloma.

The infusion is monitored closely to manage any immediate reactions.

4 supportive care

During the treatment, supportive medications such as tocilizumab and dexchlorpheniramine may be administered intravenously to manage side effects.

Oral medications like allopurinol and paracetamol are also used to support the patient’s comfort and health.

5 monitoring and follow-up

After the main treatment, regular monitoring is conducted to assess the response and manage any complications.

This includes checking for any signs of cytokine release syndrome or other toxicities, and evaluating the persistence of the treatment in the body.

6 long-term evaluation

The study continues to monitor the patient’s health and response to treatment over an extended period, up to the estimated end date in 2029.

This phase focuses on overall survival, disease progression, and any long-term effects of the treatment.

Who Can Join the Study?

Patients must be older than 18 years.
Patients must have a condition called multiple myeloma that has returned after a type of transplant called an allogeneic transplant.
Patients must have had at least two different treatments for their condition, either before or after the allogeneic transplant.
Patients must not be taking medications that suppress the immune system for at least one month before joining the study and must not have an active condition called GVHD (graft-versus-host disease).
Patients must have an ECOG functional status of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed.
Patients must have a life expectancy of more than three months.
Patients must agree to participate by signing a document called the Informed Consent.

Who Cannot Join the Study?

Patients who have not experienced a relapse of multiple myeloma after an allogeneic transplant. An allogeneic transplant is a procedure where a patient receives stem cells from a donor.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hkboujdl Uibkgjkudxbva Mrmttme Dd Vdclaqxkfe	Santander	Spain
Hfxhwngl Dn Le Sgzmh Cjnd I Slcj Pok	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.03.2025

Trial locations

Investigated drugs:

HUVR-CARTemis-1 is a type of therapy that uses specially modified T-lymphocytes, which are a kind of white blood cell. These cells are engineered to target and attack cancer cells in patients with multiple myeloma, a type of blood cancer. The therapy is designed to help the immune system recognize and destroy cancer cells more effectively. In this trial, the focus is on assessing how feasible it is to produce this therapy and how safe it is for patients who have experienced a relapse of their cancer after undergoing an allogeneic transplant.

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, patients may experience symptoms such as bone pain, frequent infections, anemia, and kidney problems. The accumulation of these abnormal cells can lead to the formation of tumors in the bones and other tissues. Over time, the disease can cause significant bone damage and increase the risk of fractures. The progression of multiple myeloma can vary, with periods of stability followed by relapses.

Trial ID:

2022-503063-15-00

Protocol code:

CARTemis-1

NCT ID:

NCT05982275

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on HUVR-CARTemis-1 Therapy for Patients with Relapsed Multiple Myeloma After Allogeneic Transplant Using a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?