CTX130 for Kidney Cancer

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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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 carcinoma.

Research Team

Alissa Keegan, MD

Principal Investigator

CRISPR Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+