CTX130 for Kidney Cancer

No longer recruiting at 6 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: CRISPR Therapeutics AG

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS, Cardiac, Pulmonary, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTX130, a type of immunotherapy, for individuals with kidney cancer that has returned or hasn't responded to standard treatments. The main goal is to determine if CTX130 is safe and effective. This treatment involves an IV infusion following some chemotherapy. Individuals with kidney cancer that cannot be surgically removed or has spread, and who have already tried other treatments, might be suitable candidates. 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 need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CTX130 is likely to be safe for humans?

Research has shown that CTX130, a new treatment under study for kidney cancer, has promising safety results. This treatment uses modified immune cells to fight cancer and has led to manageable side effects. The most common issues were mild, such as fatigue or fever, which are often expected with this type of therapy.

Earlier studies tested CTX130 in patients with advanced kidney cancer, and they generally tolerated the treatment well. While more information is still being collected, these findings suggest that CTX130 might be a safe option for those considering joining this trial. However, it is important to discuss any concerns or questions with the trial team or a healthcare provider before deciding to participate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney cancer, which often include surgery, targeted therapies, and immunotherapies, CTX130 is unique because it uses CAR-T cell therapy. This treatment involves modifying a patient's own T cells to better recognize and attack cancer cells, which is a different approach than conventional therapies. Researchers are excited about CTX130 because it targets specific proteins on the cancer cells, potentially offering a more personalized and effective treatment option with fewer side effects. Additionally, CTX130 is administered via IV infusion after lymphodepleting chemotherapy, which prepares the body to accept and support the modified T cells more effectively.

What evidence suggests that CTX130 might be an effective treatment for kidney cancer?

Research shows that CTX130, a new treatment using modified immune cells, may help treat clear cell kidney cancer. In previous studies, CTX130 halted disease progression in 77% of patients who had tried many other treatments. Most patients experienced a halt in cancer growth, and some maintained stable disease for an extended period, suggesting lasting benefits. Additionally, CTX130 has proven to be very safe, as it is generally well-tolerated by patients. These findings offer hope for its effectiveness in managing this type of kidney cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

Alissa Keegan, MD

Principal Investigator

CRISPR Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a weight of at least 42 kg who have kidney cancer that's gotten worse or hasn't responded to treatment. They must be able to perform daily activities well (KPS ≥80%) and agree to use contraception for a year post-treatment. People can't join if they've had organ transplants, previous CAR T cell therapy, certain severe health conditions, are pregnant/breastfeeding, have untreated HIV/hepatitis infections, or other active cancers.

Inclusion Criteria

I agree to use birth control from enrollment through 12 months after treatment.

I am mostly able to carry out normal activities without assistance.

My kidney cancer cannot be surgically removed and has not responded to standard treatments.

Exclusion Criteria

I have had a solid organ or bone marrow transplant.

I had cancer before but it's been treated, hasn't needed more treatment for over a year, and isn't likely to spread.

Pregnant or breastfeeding females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CTX130 infusion

1-2 weeks

Treatment

CTX130 is administered by IV infusion

1 day

Initial Follow-up

Participants are monitored for adverse events and dose-limiting toxicities

4 weeks

Long-term Follow-up

Participants are monitored for objective response rate and other outcomes

60 months

What Are the Treatments Tested in This Trial?

Interventions

• CTX130

Trial Overview The study is testing CTX130's safety and effectiveness in treating renal cell carcinoma that has relapsed or doesn't respond anymore. It's an early-phase trial where all participants receive the same experimental therapy without any comparison group.

How Is the Trial Designed?

Group I: CTX130 Experimental Treatment 1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

Who Is Running the Clinical Trial?

CRISPR Therapeutics AG

Lead Sponsor

Trials

9

Recruited

640+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215406/

CD70-Targeted Allogeneic CAR T-Cell Therapy for ... CTX130, an allogeneic CD70-targeting CAR-T cell therapy, yielded disease control in the majority of patients with clear cell renal cell carcinoma.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04438083

NCT04438083 | A Safety and Efficacy Study Evaluating ... This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell ...

3. aacrjournals.org aacrjournals.org/cancerres/article/84/7_Supplement/CT002/742428/Abstract-CT002-CTX130-allogeneic-CRISPR-Cas9

Abstract CT002: CTX130 allogeneic CRISPR-Cas9 ... Conclusions: Updated results from the COBALT-RCC study reinforce both the encouraging antitumor activity and exceptional safety profile of ...

4. crisprtx.com crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-presents-data-at-the-society-for-immunotherapy-of-cancer-sitc-37th-annual-meeting

CRISPR Therapeutics Presents Data at the… CTX130 achieved a 77% disease control rate in a heavily pretreated RCC patient population. The longest duration of stable disease achieved was ...

5. onclive.com onclive.com/view/early-responses-with-ctx130-renew-hope-for-anti-cd70-car-t-cell-therapy-in-advanced-rcc

Early Responses With CTX130 Renew Hope for Anti-CD70 ... Overall, the disease control rate (DCR) was 81.3%, the median progression-free survival (PFS) was 2.9 months (95% CI, 1.7-6.0), and the median ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04438083

NCT04438083 | A Safety and Efficacy Study Evaluating ... This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell ...

7. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00508-4/abstract

Safety and activity of CTX130, a CD70-targeted allogeneic ... Safety and activity analyses were performed on data from all patients who received CTX130. The trial is registered with ClinicalTrials.gov ...

8. onclive.com onclive.com/view/ctx130-elicits-disease-control-and-manageable-safety-in-advanced-ccrcc

CTX130 Provides Disease Control and Manageable ... The anti-CD70 CAR T-cell therapy CTX130 showed activity and manageable toxicities in advanced renal cell carcinoma.