A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Apr 10, 2027
  • participants needed
    107
  • sponsor
    CRISPR Therapeutics AG
Updated on 10 March 2021
carcinoma
karnofsky performance status

Summary

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.

Description

The study may enroll approximately 107subjects in total.

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma
Treatment CTX130
Clinical Study IdentifierNCT04438083
SponsorCRISPR Therapeutics AG
Last Modified on10 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Renal Cancer or Adenocarcinoma or Renal Cell Carcinoma?
Do you have any of these conditions: Kidney Cancer or clear cell renal cell carcinoma or Renal Cancer or Renal Cell Carcinoma or Renal Cell Cancer or Adenocarcinoma or Malignant neoplasm ...?
Do you have any of these conditions: clear cell renal cell carcinoma or Renal Cell Cancer or Malignant Adenoma or Renal Cancer or Kidney Cancer or Malignant neoplasm of kidney or Adenocar...?
Do you have any of these conditions: Kidney Cancer or Malignant neoplasm of kidney or clear cell renal cell carcinoma or Renal Cell Cancer or Adenocarcinoma or Renal Cell Carcinoma or Mal...?
Do you have any of these conditions: Adenocarcinoma or Kidney Cancer or Renal Cell Cancer or Renal Cancer or clear cell renal cell carcinoma or Renal Cell Carcinoma or Malignant Adenoma o...?
Do you have any of these conditions: clear cell renal cell carcinoma or Renal Cell Cancer or Kidney Cancer or Renal Cell Carcinoma or Malignant neoplasm of kidney or Malignant Adenoma or ...?
Do you have any of these conditions: Malignant Adenoma or Kidney Cancer or Malignant neoplasm of kidney or Renal Cell Carcinoma or Renal Cell Cancer or Renal Cancer or Adenocarcinoma or c...?
Do you have any of these conditions: Renal Cell Cancer or Malignant Adenoma or clear cell renal cell carcinoma or Renal Cell Carcinoma or Malignant neoplasm of kidney or Renal Cancer or K...?
Do you have any of these conditions: Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Adenocarcinoma or Renal Cell Cancer or clear cell renal cell carcinoma or Renal ...?
Do you have any of these conditions: Renal Cell Carcinoma or Kidney Cancer or Malignant Adenoma or Malignant neoplasm of kidney or clear cell renal cell carcinoma or Adenocarcinoma or Ren...?
Do you have any of these conditions: Adenocarcinoma or Renal Cell Carcinoma or Renal Cell Cancer or Malignant neoplasm of kidney or Malignant Adenoma or clear cell renal cell carcinoma or...?
Age 18 years and body weight 60 kg
Unresectable or metastatic RCC that has exploited standard of care treatment
Karnofsky performance status (KPS) 80%
Adequate renal, liver, cardiac, and pulmonary organ function
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 Criteria

Prior treatment with any anti-CD70 targeting agents
Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells
History of certain central nervous system (CNS), cardiac or pulmonary conditions
Active HIV, hepatitis B virus or hepatitis C virus infection
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
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy
Prior solid organ transplantation or bone marrow transplant
Pregnant or breastfeeding females
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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