NCT04438083

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_1

Geographic Reach
4 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2024

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

June 16, 2020

Last Update Submit

January 7, 2025

Conditions

Renal Cell Carcinoma

Keywords

CAR TAllogeneicRenal cell carcinomaRenal cell carcinoma with clear cell differentiationCRISPR-Cas9

Outcome Measures

Primary Outcomes (2)

  • Part A (dose escalation): Incidence of adverse events

    Adverse events defined as dose-limiting toxicities

    From CTX130 infusion up to 28 days post-infusion

  • Part B (cohort expansion): Objective response rate

    Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    From CTX130 infusion up to 60 months post-infusion]

Secondary Outcomes (2)

  • Progression Free Survival

    From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months

  • Overall Survival

    From date of CTX130 until date of death due to any cause, assessed up to 60 months

Study Arms (1)

CTX130

EXPERIMENTAL

Administered by IV infusion following lymphodepleting chemotherapy.

Biological: CTX130

Interventions

CTX130BIOLOGICAL

CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

CTX130

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years and body weight ≥42 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site 2

Duarte, California, 91010, United States

Location

Research Site 5

Hartford, Connecticut, 06520, United States

Location

Research Site 4

Houston, Texas, 77030, United States

Location

Research Site 3

Salt Lake City, Utah, 84112, United States

Location

Research Site 1

Melbourne, Victoria, 3000, Australia

Location

Research Site 6

Toronto, Ontario, M5G 2M9, Canada

Location

Research Site 7

Amsterdam, North Holland, 1066, Netherlands

Location

Related Publications (1)

  • Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.

    PMID: 37093350DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Alissa Keegan, MD

    CRISPR Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

June 16, 2020

Primary Completion

October 8, 2024

Study Completion

October 8, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

CA(1)US(4)NL(1)AU(1)