CD70.CAR for Cancer
(CALySSEY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment using specialized immune cells called CAR T cells to target cancers displaying the protein CD70. The goal is to test the safety and potential effectiveness of this therapy for individuals whose cancer, such as lymphoma, myeloma, or certain solid tumors, has returned after standard treatments. Participants should have a CD70-positive tumor with at least 26% of the tumor cells showing this protein and have experienced a recurrence or lack of success with typical treatments.
As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic chemotherapy at least 2 weeks before starting the study treatment. It also excludes those currently on high-dose steroids or certain other treatments. Please discuss your specific medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research shows that CD70-targeted CAR T cells are under study for safety and effectiveness in treating certain cancers. For patients with T-cell lymphoma, studies have found that a similar treatment, CTX130, can be administered safely. The side effects were manageable, indicating they were not severe and could be handled well, suggesting patients tolerated the treatment well.
For myeloma, early studies on CD70-targeted CAR T cells have shown promise regarding safety. The treatment was effective without causing major safety issues, meaning that while some side effects could occur, they were not serious enough to halt the treatment.
These findings provide some confidence that CD70-targeted CAR T cells may be safe for people with these cancers. However, this specific trial remains in its early phase, primarily aiming to test safety. While earlier studies offer hope, the main goal here is to carefully monitor for any side effects and ensure the treatment is safe for everyone involved.12345Why are researchers excited about this study treatment?
CD70.CAR is unique because it uses a novel approach called CAR-T cell therapy to target cancer cells. Unlike traditional chemotherapy that attacks cancer broadly, CAR-T cell therapy involves modifying a patient's T cells to specifically seek out and destroy cancer cells expressing the CD70 protein. Researchers are excited about this treatment because it has the potential to provide a more precise, potent attack on tumors with fewer side effects compared to broad-spectrum treatments. Additionally, CD70.CAR's ability to target both lymphoma and solid tumors, as well as myeloma, could mean a wider range of applications for patients with different types of cancer.
What evidence suggests that this trial's treatments could be effective for cancer?
Research shows that CD70.CAR T cells could offer a promising new way to treat certain cancers. Earlier studies have found that treatments targeting CD70 are effective, particularly for blood cancers like lymphoma and myeloma, which often express the CD70 protein. In this trial, participants in Treatment Arm A will receive CD70.CAR T cells for lymphoma and solid tumors, while those in Treatment Arm B will receive the same treatment for myeloma. In myeloma, CD70 is associated with more severe cases and lower survival rates, so targeting it might help control the disease. While CAR T therapy has proven effective for blood cancers, its effects on solid tumors, such as some sarcomas and kidney cancers, remain under investigation, with early results appearing hopeful. These specially designed CAR T cells can grow and persist longer, enhancing their ability to fight cancer cells.16789
Who Is on the Research Team?
Bilal Omer, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for patients with cancers like lymphoma, myeloma, sarcomas, and kidney cancer that express CD70 protein. These cancers should be persistent or recurrent after standard treatments. Participants must have limited or no remaining standard treatment options.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment Chemotherapy
Participants receive cyclophosphamide and fludarabine to decrease T cell numbers before CAR T cell infusion
Treatment
Participants receive an infusion of CD70 CAR T cells and are monitored for immediate adverse effects
Initial Follow-up
Participants are monitored for safety and effectiveness, including blood tests and scans
Long-term Follow-up
Participants are monitored for long-term side effects of gene transfer
What Are the Treatments Tested in This Trial?
Interventions
- CD70.CAR
Trial Overview
The study tests 'CAR T cells' targeting the CD70 protein on tumor cells. It aims to find a safe dose of these genetically modified immune cells, understand side effects, and assess their effectiveness against certain blood and solid tumors.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with myeloma. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.
CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with lymphoma and solid tumors. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator
The Methodist Hospital Research Institute
Collaborator
Citations
CD70 as a target in cancer immunotherapy - PubMed Central
CAR-T therapy has demonstrated remarkable success in treating hematologic malignancies, but its efficacy against solid tumors remains limited.
CD70.CAR for CD70+ Lymphoma, Myeloma and Solid ...
The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy ...
CD70-targeted CAR-T/NK therapy: Rationale, advances, ...
The effectiveness of CAR-T cells targeting CD70 in combating tumors is associated with the level of CD70 on the surface of AML tumor cells, which exhibits ...
4.
hematologyadvisor.com
hematologyadvisor.com/news/lymphoma-tcell-cd70-directed-cart-therapy-promising-treatment/CD70-Directed CAR-T Therapy Shows Promise in T-Cell ...
This study shows that allogeneic, readily available CAR T cells can be safely given to patients with relapsed or refractory T-cell lymphoma.
5.
ashpublications.org
ashpublications.org/bloodadvances/article/8/11/2635/515576/CD70-specific-CAR-NK-cells-expressing-IL-15-forCD70-specific CAR NK cells expressing IL-15 for the ...
CD70-CAR NK cells displayed superior cytotoxic activity in vitro and in vivo against CD19-negative B-cell lymphoma when compared with nontransduced NK cells ...
Safety and activity of CTX130, a CD70-targeted allogeneic ...
This study shows that allogeneic, readily available CAR T cells can be safely given to patients with relapsed or refractory T-cell lymphoma. A ...
CD70: An emerging target for integrated cancer diagnosis and ...
Corresponding phase I/II clinical trials are currently underway to assess the safety and efficacy of CAR27‐28ζ NK cells in patients with CD70‐ ...
Study Details | NCT07181720 | CD70-Targeted CAR-T ...
To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability] ...
Safety and activity of CTX130, a CD70-targeted allogeneic ...
In patients with heavily pretreated T-cell lymphoma, CTX130 showed manageable safety and a promising objective response rate. This study shows that allogeneic, ...
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