NCT05795595

Brief Summary

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

Trial Health

87
On Track

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 Mar 2023

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

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

Study Start

First participant enrolled

March 13, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

March 21, 2023

Last Update Submit

November 21, 2025

Conditions

Clear Cell Renal Cell CarcinomaCervical CarcinomaEsophageal CarcinomaPancreatic AdenocarcinomaMalignant Pleural Mesothelioma

Keywords

CAR-TAllogeneicCarcinoma

Outcome Measures

Primary Outcomes (2)

  • Phase 1 (Dose Escalation): Incidence of adverse events

    Defined as dose-limiting toxicities

    From CTX131 infusion up to 28 days post-infusion

  • Phase 2 (Cohort Expansion): Objective response rate (ORR)

    ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology

    From CTX131 infusion up to 60 months post-infusion

Study Arms (1)

CTX131

EXPERIMENTAL

Administered by IV infusion following lymphodepleting chemotherapy.

Biological: CTX131

Interventions

CTX131BIOLOGICAL

CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

CTX131

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years.
  • Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
  • Eastern Cooperative Oncology Group performance status 0 or 1.
  • 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 CTX131 infusion.

You may not qualify if:

  • Prior treatment with anti-CD70 targeting agents
  • History of certain central nervous system (CNS), cardiac or pulmonary conditions.
  • Presence of uncontrolled bacterial, viral, or fungal infection.
  • Active HIV, hepatitis B virus or hepatitis C virus infection.
  • Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  • Women who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site 3

Duarte, California, 91010, United States

Location

Research Site 7

Chicago, Illinois, 60637, United States

Location

Research Site 6

Boston, Massachusetts, 02215, United States

Location

Research Site 2

St Louis, Missouri, 63110, United States

Location

Research Site 4

Durham, North Carolina, 27710, United States

Location

Research Site 1

Nashville, Tennessee, 37203, United States

Location

Research Site 5

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellUterine Cervical NeoplasmsEsophageal NeoplasmsMesothelioma, MalignantCarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesMesotheliomaAdenomaNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract Diseases

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

March 21, 2023

First Posted

April 3, 2023

Study Start

March 13, 2023

Primary Completion

September 18, 2025

Study Completion

September 18, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(7)