24 Participants Needed

TriCAR19.20.22 T Cells for Blood Cancers

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ohio State University Comprehensive Cancer Center
Must be taking: BTK inhibitors, Venetoclax
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 tests a new treatment called TriCAR19.20.22 T cells to determine its safety and effectiveness for blood cancers like non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL) that have recurred or resisted treatment. The treatment involves modifying a patient's immune cells in a lab to enhance their ability to attack cancer cells. This trial may suit individuals whose cancer has returned after treatment or did not improve with previous therapies. 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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be off immunosuppressive agents if you had an allogeneic stem cell transplant, and there are specific requirements for those with hepatitis B. It's best to discuss your current medications with the trial team to get a clear answer.

Is there any evidence suggesting that TriCAR19.20.22 T cells are likely to be safe for humans?

Research shows that TriCAR19.20.22 T cells might be safe and manageable for patients with certain blood cancers. These T cells are designed to find and attack specific proteins (CD19, CD20, and CD22) on cancer cells. Studies have shown that CAR T-cell therapies targeting these proteins have effectively treated blood cancers. So far, the treatments seem well-tolerated, with most patients not experiencing severe side effects. However, because this trial is in an early phase, researchers are still collecting detailed safety information. While there is some understanding of safety, more research is needed for a complete picture.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about TriCAR19.20.22 T cells because they offer a novel approach for treating blood cancers by targeting three specific proteins on cancer cells: CD19, CD20, and CD22. This multi-target strategy is distinct from standard therapies like chemotherapy and single-target CAR T-cell therapies, which often focus on just one protein. By simultaneously attacking multiple targets, TriCAR19.20.22 T cells have the potential to reduce cancer recurrence and improve treatment effectiveness. Additionally, these T cells are administered directly into the bloodstream, potentially leading to quicker and more direct action against the cancer cells.

What evidence suggests that TriCAR19.20.22 T cells might be an effective treatment for blood cancers?

Research shows that TriCAR19.20.22 T cells, which target specific proteins (CD19, CD20, and CD22) on cancer cells, could be promising for treating blood cancers. In this trial, participants will receive TriCAR19.20.22 T cells, with some receiving the treatment on day 0 and others on both days 0 and 7. Studies on similar CAR T-cell therapies have shown that more patients experience their cancer shrinking or stopping growth. This method involves altering a patient's immune cells to enhance their ability to fight cancer. Combining these targets might improve treatment for difficult-to-treat forms of non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). Early results suggest that this triple-targeted therapy is safe and may work for some patients.13467

Who Is on the Research Team?

SV

Sumithira Vasu, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with certain blood cancers (like non-Hodgkin lymphoma, acute lymphoblastic leukemia, and chronic lymphocytic leukemia) that have returned or didn't respond to previous treatments. Specific eligibility criteria are not provided but typically include factors like age, health status, cancer type and stage.

Inclusion Criteria

Cohort assignment at discretion of principal investigator (PI) depending on patient disease/history
Total bilirubin ≤ 1.5 times the institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≥ 3 x institutional upper limit of normal
See 20 more

Exclusion Criteria

Active graft versus host disease
It has been at least 28 days since my last experimental treatment.
My lymphoma or leukemia has spread to my brain or spinal cord.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Apheresis

Patients undergo apheresis to collect T cells for modification

1 week
1 visit (in-person)

Lymphodepletion Chemotherapy

Patients receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine

4 days
Daily visits (in-person)

CAR T-cell Infusion

Patients receive TriCAR19.20.22 T cells infusion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years
Regular visits at 7, 14, 21, 30, 60, and 90 days, at 6 and 12 months, then yearly

What Are the Treatments Tested in This Trial?

Interventions

  • TriCAR19.20.22 T Cells
Trial Overview The trial is testing a new therapy called TriCAR19.20.22 T cells on patients whose blood cancer has relapsed or is refractory. It involves modifying the patient's own immune cells to target and attack their cancer cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort B (TriCAR19.20.22 T cells)Experimental Treatment11 Interventions
Group II: Cohort A (TriCAR19.20.22 T cells)Experimental Treatment11 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

Anti-CD19/20/22 Chimeric Antigen Receptor T Cells ...20.22 T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.
TriCAR19.20.22 T Cells for Blood Cancers20.22 T cells may be safe, tolerable, and/or effective in treating patients ... 20.22 T cells on patients whose blood cancer has relapsed or is refractory.
TriCAR19.20.22 T cells / The Ohio State University ...First-in-Human Phase I Study Results Presented: Trispecific CAR T-Cell Therapy (Blood Cancers Today) - P1 | N=36 | NCT05418088 | "A first-in-human phase I ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40433368/
Efficacy and safety of CD19 combined with CD22 or CD20 ...The data from this study suggest that CD19 combined with CD22 CAR T-cell therapy had a higher partial response rate in the treatment of hematologic ...
Study Details | NCT07168486 | CD19.20.22 CAR T-cells ...This is a phase 1a, open-label, single center study evaluating the safety and efficacy CAR19.20.22 in subjects with r/r B-cell malignancies. The ...
Efficacy and safety of CD19 combined with CD22 or CD20 ...CD20 and CD22 CAR-T immunotherapies have achieved good results in hematological malignancies, including cases in which patients have previously ...
Efficacy and safety of CD22-specific and CD19/ ...... safety of anti-CD22 or anti-CD19/CD22 CAR-T cell therapy in the treatment of hematological malignancies. 2) Outcomes included complete ...
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