Long-term Safety Study of CRISPR CAR T Cell Therapy for Patients with Blood and Solid Cancers

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for people with certain types of cancer, specifically hematologic malignancies and solid malignancies. The treatment being studied involves a special type of cell therapy called CRISPR CAR cellular therapy. This therapy uses advanced genetic techniques to modify immune cells, known as CAR T cells, to help them target and fight cancer cells more effectively.

The purpose of this study is to monitor the safety of this treatment over an extended period. Participants in the study have already received the CRISPR CAR cellular therapy. The study will track any side effects or adverse events that may occur, including serious ones, to ensure the treatment is safe for long-term use. Additionally, the study will look at how long participants survive and how long they remain in remission, which means the cancer is not active or growing.

Throughout the study, participants will be regularly monitored by healthcare professionals. This will involve routine check-ups and assessments to gather information about their health and any changes they experience. The study aims to provide valuable insights into the long-term effects of CRISPR CAR cellular therapy, contributing to the understanding and development of new cancer treatments.

1 joining the study

Upon joining the study, the participant must have already received CRISPR CAR cellular therapy. This therapy involves the use of genetically modified cells to target specific cancer cells.

The participant must be able to understand and comply with the study procedures and sign a consent form.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s current health status. This includes reviewing medical history and any previous treatments received.

The assessment aims to ensure the participant meets all necessary criteria for the study.

3 treatment monitoring

Participants will be monitored for any adverse events related to the CRISPR CAR cellular therapy. This includes any unexpected medical issues that may arise.

Monitoring will focus on both serious adverse events and those of special interest, ensuring participant safety throughout the study.

4 long-term follow-up

The study involves a long-term follow-up to assess the overall survival and duration of remission or response to the therapy.

Participants will be regularly evaluated to track their health status and any changes over time.

5 study completion

The study is estimated to conclude by August 31, 2039. Participants will continue to be monitored until the end of the study period.

Final assessments will be conducted to gather comprehensive data on the long-term effects of the therapy.

Who Can Join the Study?

The patient must be able to understand and follow the study procedures and must agree to participate by signing a consent form.
The patient must have already received CRISPR CAR cellular therapy. This is a type of treatment that uses a special technology to modify cells to help fight cancer.
The study is open to both male and female patients.
The study includes patients with hematologic malignancy (cancers that start in blood-forming tissue) or solid malignancy (cancers that form in solid organs or tissues).
The study is not specifically for vulnerable populations, meaning it does not focus on groups that might need special protection.

Who Cannot Join the Study?

Patients with certain types of cancer, such as hematologic malignancy (cancers that start in blood-forming tissue) or solid malignancy (cancers that form solid tumors), may not be eligible.
Individuals who are not within the specified age range for the study may be excluded. The study is open to certain age groups only.
Participants who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uahocpksxj Mmpklsj Cdbcjw Hfxlzdtezrvvxnffd	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Allogeneic Crispr/Cas9-Mediated Genetically Modified Car T Cells Targeting Cd19 Antigen

CRISPR CAR Cellular Therapy is a type of treatment that uses a patient’s own immune cells, which are modified in the laboratory using CRISPR technology. This modification helps the immune cells better recognize and attack cancer cells. The therapy is designed to treat various types of blood cancers and solid tumors by enhancing the body’s natural ability to fight cancer.

Investigated diseases:

Haematological malignancy

Hematologic Malignancy – This term refers to cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These malignancies can lead to the production of abnormal blood cells, which can interfere with normal blood functions. As the disease progresses, it may cause symptoms like fatigue, frequent infections, and easy bruising or bleeding. Hematologic malignancies include various types such as leukemia, lymphoma, and myeloma. The progression can vary significantly depending on the specific type and subtype of the malignancy.

Solid Malignancy – This term encompasses a group of cancers that form solid tumors in organs or tissues, excluding blood-related cancers. These tumors can occur in various parts of the body, such as the breast, lung, prostate, or colon. As solid malignancies grow, they may invade nearby tissues and organs, potentially causing symptoms related to the affected area. The progression of solid malignancies can vary widely, with some growing slowly and others more aggressively. The growth and spread of these tumors can lead to physical changes and discomfort in the affected region.

Trial ID:

2024-512479-11-00

Protocol code:

CRSP-ONC-LTF

NCT ID:

NCT06208878

Trial Phase:

Human Pharmacology (Phase I) – Other

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Long-term Safety Study of CRISPR CAR T Cell Therapy for Patients with Blood and Solid Cancers

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