Solid TumorEarly Phase 1NCT05638828
A Study of RD14-01 in Patients With Advanced Solid Tumors
A Early Phase 1 study testing RD14-01 Cell injection in people with Solid Tumor, run by Shen Lin.
Trial summary
This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- RD14-01 Cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2024
- Phase
- Early 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
Who may be able to join
- Age ≥18 years.
- Patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available.
- ROR1+ by central laboratory immunohistochemistry (IHC).
- Adequate organ and marrow function.
- At least one measurable lesion as per RECIST v1.1.
- . Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Ability to understand and provide informed consent.
Who cannot join
- Prior treatment with any agent targeting ROR1
- Presence of active central nervous system (CNS) metastasis
- Impaired cardiac function or clinically significant cardiac disease
- Untreated or active infection at the time of screening or leukapheresis
- HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis
- Untreated or active infection at the time of screening or leukapheresis
- Pregnant or breast-feeding females
Trial locations and contacts
No sites are listed yet.
About this study
This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.
Read the detailed description
This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .
- Conditions
- Solid Tumor
- Being tested
- RD14-01 Cell injection
- Keywords
- CAR-T Cell, ROR1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD14-01 Cell injectionDrug
RD14-01 Cell injection
| Study group | Role | What they receive |
|---|---|---|
| Cell injection | Experimental | Not described Receives: Drug: RD14-01 Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT and MTD
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
Measured: up to 28 days
TEAEs
Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence.
Measured: up to 12 months
Secondary outcomes (7)
ORR
Overall Response Rate (ORR) by RECIST, version 1.1
Measured: up to 28 days
DOR
Duration of response (DOR)
Measured: up to 12 months
PFS
Progression Free Survival(PFS)
Measured: up to 12 months
OS
Overall Survival (OS)
Measured: up to 12 months
Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
Measured: up to 12 months
Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples
Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples
Measured: up to 12 months
Persistence of RD14-01 CAR T cells in peripheral blood samples
Persistence of RD14-01 CAR T cells in peripheral blood samples
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, Prof. Dr., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638828
- Sponsor's protocol ID
- BHCT-RD14-01-03
- Status last verified
- Sep 2022
- First submitted
- 28 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of RD14-01 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05638828
- Acronym / sponsor ID
- BHCT-RD14-01-03
- Conditions
- Solid Tumor
- Keywords
- CAR-T Cell, ROR1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Dec 2022 (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 study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.
Detailed description
This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell injection | Experimental | Drug: RD14-01 Cell injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available.
- ROR1+ by central laboratory immunohistochemistry (IHC).
- Adequate organ and marrow function.
- At least one measurable lesion as per RECIST v1.1.
Key exclusion criteria (7 listed)
- Prior treatment with any agent targeting ROR1
- Presence of active central nervous system (CNS) metastasis
- Impaired cardiac function or clinically significant cardiac disease
- Untreated or active infection at the time of screening or leukapheresis
- HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis
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 |
|---|---|---|
| RD14-01 Cell injectionRD14-01 Cell injection | Drug | Cell injection |
Primary outcome
DLT and MTD
Time frame: up to 28 days
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
TEAEs
Time frame: up to 12 months
Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence.
7 secondary outcomes
ORR
Time frame: up to 28 days
DOR
Time frame: up to 12 months
PFS
Time frame: up to 12 months
OS
Time frame: up to 12 months
Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
Time frame: up to 12 months
Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples
Time frame: up to 12 months
Persistence of RD14-01 CAR T cells in peripheral blood samples
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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.
Lin Shen, Prof. Dr. principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RD14-01 Cell injection in people with Solid Tumor, run by Shen Lin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changsong Qi, Dr. (13811394004, xiwangpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT and MTD (time frame: up to 28 days). 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?
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 6 Dec 2022.