CAR T Cell Therapy for T-Cell Leukemia

Not yet recruiting at 1 trial location

Overseen By LaQuisa Hill, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Baylor College of Medicine

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Active infection, Other cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with T-cell leukemia or lymphoma, types of blood and lymph gland cancers. Researchers combine T cells (infection-fighting blood cells) with an antibody called anti-CD7 to help the T cells better target cancer cells. The study aims to evaluate the effectiveness of these modified T cells, enhanced with a protein called CD28, in fighting the cancer. It is suitable for those whose T-cell leukemia or lymphoma has returned after a specific type of stem cell transplant and who have a suitable donor.

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 does not specify if you need to stop taking your current medications, but it does exclude participants who are currently receiving investigational agents or taking corticosteroids above a certain dose. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that CD7 CAR-T cell therapy offers promising results for treating T-cell leukemia and lymphoma. In some studies, these specially designed T cells have led to complete remission, meaning the cancer signs disappear, in many patients. For instance, one study found that 90% of participants experienced complete remission.

The treatment's safety is still under investigation. Researchers closely monitor patient responses. Some side effects have been reported, which is common with new treatments. These side effects can vary, and understanding them is why studies like this are important. They help doctors learn how well people handle the treatment and what risks might exist.

This therapy is not yet approved by the FDA, so these trials are a key step in learning more about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for T-cell leukemia, which typically involve chemotherapy and radiation, CD7.CAR/28zeta T Cells offer a novel approach by using genetically engineered T cells to target cancer cells. This therapy works by reprogramming the body's own immune cells to recognize and eliminate cancer cells more effectively. Researchers are excited about this treatment because it has the potential to be more precise and effective, with potentially fewer side effects than traditional options. Additionally, this approach could provide a significant breakthrough for patients who have not responded well to conventional therapies.

What evidence suggests that CD7.CAR/28zeta T Cells might be an effective treatment for T-cell leukemia or lymphoma?

Studies have shown that CD7 CAR-T cells, specially modified T cells designed to attack the CD7 protein on cancer cells, have a high success rate. In one trial, 90% of patients achieved complete remission, with no detectable cancer after treatment. This therapy employs a special protein, CD28, to enhance T cell growth and longevity, boosting their cancer-fighting ability. Long-term follow-up studies also indicate that this treatment can provide lasting benefits for some patients with difficult-to-treat T-cell leukemia. The combination of targeting CD7 and using CD28 support makes this a promising treatment option. Participants in this trial will receive CD7.CAR/28zeta T Cells following lymphodepleting chemotherapy with cyclophosphamide and fludarabine. ^{1 2 3 4 6}

Who Is on the Research Team?

LaQuisa Hill, MD

Principal Investigator

The Methodist Hospital Research Institute

Rayne Rounce, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with specific blood cancers, including T-cell leukemia and lymphoma. Participants must have a type of cancer that has CD7 on the cell surface. The study excludes individuals who don't meet certain health criteria set by researchers.

Inclusion Criteria

Life expectancy greater than 12 weeks

Hgb ≥ 7.0 g/dL (can be transfused)

Available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol for uncontrolled EBV reactivation

Exclusion Criteria

Currently receiving any investigational agents or having received any tumor vaccines within the previous 4 weeks

History of hypersensitivity reactions to murine protein-containing products

Pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine to prepare for T cell infusion

1 week

3 visits (in-person)

T Cell Infusion

Participants receive an infusion of CD7 chimeric receptor-T cells

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness after T cell infusion

4-6 weeks

Weekly visits (in-person)

Long-term Follow-up

Participants are monitored for long-term side effects of gene transfer

15 years

Every 6 months for 4 years, then yearly

What Are the Treatments Tested in This Trial?

Interventions

• CD7.CAR/28zeta T Cells

Trial Overview The trial tests a new therapy using modified T cells with an anti-CD7 chimeric receptor and CD28 to boost their effectiveness against cancer. These engineered T cells are designed to better recognize and kill cancer cells.

How Is the Trial Designed?

Group I: CD7.CAR/28zeta T Cells Experimental Treatment 1 Intervention

Four dose levels will be evaluated. The T cells will be administered following lymphodepleting chemotherapy with cyclophosphamide and fludarabine.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12327587/

CD7 CAR-T therapy: current developments, improvements, ... The trial achieved a CR rate of 90% (18/20), with CD7 CAR-T cells demonstrating robust expansion and effective anti-leukemia activity in vivo.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03690011

Study Details | NCT03690011 | Cell Therapy for High Risk ... Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1478888/full

The efficacy and safety of CD7 chimeric antigen receptor T ... This study summarizes the currently published clinical research results on CD7 CAR-T cells and evaluates the safety and effectiveness of CD7 CAR-T cell therapy.

4. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01427-3

Long-term follow-up of donor-derived CD7 CAR T-cell therapy ... In this 2-year follow-up analysis, donor-derived CD7 CAR T-cell treatment demonstrated durable efficacy in a subset of patients with r/r T-ALL.

5. haematologica.org haematologica.org/article/view/haematol.2023.283848

Chimeric antigen receptor T-cell therapy for T-cell acute ... In this article, we discuss potential targets for CAR T-cell therapy of T-ALL with an emphasis on CD7, and review CAR configurations as well as early clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11752923/

The efficacy and safety of CD7 chimeric antigen receptor T ... This study summarizes the currently published clinical research results on CD7 CAR-T cells and evaluates the safety and effectiveness of CD7 CAR-T cell therapy.