CRSP-ONC-003: Phase 1 study of CTX130 in Renal Cell Carcinoma

• Research type

  Research Study

• Full title

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

• IRAS ID

  297731

• Contact name

  Fiona Thistlethwaite

• Contact email

  Fiona.Thistlethwaite@nhs.net

• Sponsor organisation

  CRISPR Therapeutics AG

• Eudract number

  2019-004513-14

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  5 years, 3 months, 0 days

• Research summary

  This is an open-label study. The goal of this study is to determine the recommended dose of CTX130 and then see if it affects the course of disease over time and does not cause unacceptable side effects. This study is being done to learn more about the safety and efficacy of CTX130 in participants with unresectable or metastatic (cancer that is non-operable and has spread from its original location in the body) clear cell renal cell carcinoma (ccRCC).

  The study has two parts, Part A and Part B, investigators will decide what group to place participants in. In Part A (“dose escalation”), the goal will be to determine the recommended dose and safety profile of CTX130. Participants will receive different doses of CTX130 to each other. Participants in Part A will be assigned to one of four groups. The goal of these four groups is to determine the safety and efficacy of CTX130 as either a single dose (Group A1), with multiple doses (Group A2), as a single dose with daratumumab (Group A3) or with multiple doses and daratumumab (Group A4).

  Part B (“expansion”), will continue to learn about the side effects and anti-cancer effects of CTX130, at the recommended dose and number of doses determined from Part A.

  There will be up to 36 participants in each group of part A (4 groups in total, A1, A2, A3 and A4). The study may be expanded to include approximately 71 additional participants in Part B.

  Study procedures include: physical examinations, blood tests, biopsies, CT/MRI scans, ECGs and Echocardiograms.
  

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/LO/0620

• Date of REC Opinion

  28 Oct 2021

• REC opinion

  Further Information Favourable Opinion