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Closed (no longer recruiting)Last updated: 5 February 2024

CRSPR: This phase I trial will assess the safety and effectiveness of a new type of immunotherapy, known as CAR T-cell therapy, in patients with advanced renal cell carcinoma that has got worse or not responded to prior treatmentA Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation

Clinical summary

Summary

This is a does escalation and expansion trial. Eligible patients will be sequentially assigned to receive CTX130 CD70-directed T-cell immunotherapy by IV-infusion following lymphodepleting chemotherapy.

Conditions

This trial is treating patients with renal cell carcinoma.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

Trial Acronym

CRSPR

More information

Trial Identifiers

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Trial sponsor

CRISPR Therapeutics AG

Scientific Title

A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation

Eligibility

Inclusion

  1. Age ≥18 years and body weight ≥42 kg.
  2. Unresectable or metastatic RCC that has exploited standard of care treatment.
  3. Karnofsky performance status (KPS) ≥80%.
  4. Adequate renal, liver, cardiac, and pulmonary organ function.
  5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Exclusion

  1. Prior treatment with any anti-CD70 targeting agents.
  2. Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
  3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
  4. Active HIV, hepatitis B virus or hepatitis C virus infection.
  5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
  6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  7. Prior solid organ transplantation or bone marrow transplant.
  8. Pregnant or breastfeeding females.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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