Renal Cell CarcinomaPhase 1NCT04438083
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
A Phase 1 study testing CTX130 in people with Renal Cell Carcinoma, run by CRISPR Therapeutics AG at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- CTX130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 16 Jun 2020to 8 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Abbreviated Inclusion Criteria:
- 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.
Abbreviated 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
Research Site 2
Duarte, California, 91010
Research Site 5
Hartford, Connecticut, 06520
Research Site 4
Houston, Texas, 77030
Research Site 3
Salt Lake City, Utah, 84112
About this study
Official 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
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.
Read the detailed description
The study may enroll approximately 107subjects in total.
- Conditions
- Renal Cell Carcinoma
- Being tested
- CTX130
- Keywords
- CAR T, Allogeneic, Renal cell carcinoma, Renal cell carcinoma with clear cell differentiation, CRISPR-Cas9
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX130Biological
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
| Study group | Role | What they receive |
|---|---|---|
| CTX130 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. Receives: Biological: CTX130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (dose escalation): Incidence of adverse events
Adverse events defined as dose-limiting toxicities
Measured: 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
Measured: From CTX130 infusion up to 60 months post-infusion]
Secondary outcomes (2)
Progression Free Survival
Measured: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Measured: From date of CTX130 until date of death due to any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start16 Jun 2020
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Why it stopped: Patients to be followed up in the CRSP-ONC-LTF study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRISPR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alissa Keegan, MD, Study director, CRISPR Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438083
- Sponsor's protocol ID
- CRSP-ONC-003
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2020
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37093350
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04438083
- Acronym / sponsor ID
- CRSP-ONC-003
- Conditions
- Renal Cell Carcinoma
- Keywords
- CAR T, Allogeneic, Renal cell carcinoma, Renal cell carcinoma with clear cell differentiation, CRISPR-Cas9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients to be followed up in the CRSP-ONC-LTF study
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CRISPR Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study may enroll approximately 107subjects in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTX130 | Experimental | Biological: CTX130Administered by IV infusion following lymphodepleting chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX130CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components. | Biological | CTX130 |
Primary outcome
Part A (dose escalation): Incidence of adverse events
Time frame: From CTX130 infusion up to 28 days post-infusion
Adverse events defined as dose-limiting toxicities
Part B (cohort expansion): Objective response rate
Time frame: From CTX130 infusion up to 60 months post-infusion]
Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
2 secondary outcomes
Progression Free Survival
Time frame: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Time frame: From date of CTX130 until date of death due to any cause, assessed up to 60 months
Results and safety
The study was stopped early (reason given: Patients to be followed up in the CRSP-ONC-LTF study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 37093350Dewulf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alissa Keegan, MD study director
CRISPR Therapeutics
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTX130 in people with Renal Cell Carcinoma, run by CRISPR Therapeutics AG at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patients to be followed up in the CRSP-ONC-LTF study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A (dose escalation): Incidence of adverse events (time frame: From CTX130 infusion up to 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.