Solid TumorPhase 1/2NCT05748938
A Study of RD14-01 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing RD14-01 in people with Solid Tumor, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
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 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- RD14-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2023to 8 Feb 2025
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and < 70 years old, gender unlimited;
- Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology;
- Subjects who failed or were intolerant to standard treatment, or lacked effective treatment;
- ROR1+ by central laboratory immunohistochemistry (IHC);
- Adequate organ and marrow function;
- At least one measurable lesion as per RECIST v1.1;
- Estimated survival ≥3 months;
- 7.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 8.Ability to understand and provide informed consent.
Who cannot join
- Prior treatment with any agent targeting ROR1;
- Received anti-tumor therapy within 4 weeks prior to the start of treatment, including chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning);
- Presence of active central nervous system (CNS) metastasis;
- There is or has been a history of severe cardiovascular disease;
- There is an uncontrolled pleural, abdominal or pericardial effusion
- HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis;
- Pregnant or breast-feeding females;
- There is a known or suspected failure to comply with the study protocol (for example, alcohol abuse, drug dependence, or psychological disorders) or any condition that the investigator believes may increase the subjects' risk or interfere with the results of the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650000
Sanbin Wang, Doctor, (+86)13187424131, Sanbin1011@163.com
About this study
Official title: A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors
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.
- Conditions
- Solid Tumor
- Being tested
- RD14-01
- Keywords
- Solid Tumor, CAR-T Cell, ROR1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD14-01Biological
Also called CAR-T infusion
ROR1 Targeted CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| RD14-01 treated group | Experimental | Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy. Receives: Biological: RD14-01 |
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 after infusion
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 after infusion
Secondary outcomes (6)
ORR
Overall Response Rate (ORR) by RECIST, version 1.1
Measured: up to 28 days after infusion
DOR
Duration of response (DOR)
Measured: up to 12 months after infusion
PFS
Progression Free Survival(PFS)
Measured: up to 12 months after infusion
OS
Overall Survival (OS)
Measured: up to 12 months after infusion
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 after infusion
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 after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start8 Feb 2023
- Primary completion8 Aug 2024 (estimated)
- Study completion8 Feb 2025 (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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Doctor, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748938
- Sponsor's protocol ID
- BHCT-RD14-01-02
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05748938
- Acronym / sponsor ID
- BHCT-RD14-01-02
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, CAR-T Cell, ROR1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 8 Aug 2024 (estimated)
- Study completion
- 8 Feb 2025 (estimated)
- First posted
- 1 Mar 2023 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD14-01 treated group | Experimental | Biological: RD14-01Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old and < 70 years old, gender unlimited;
- Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology;
- Subjects who failed or were intolerant to standard treatment, or lacked effective treatment;
- ROR1+ by central laboratory immunohistochemistry (IHC);
- Adequate organ and marrow function;
Key exclusion criteria (8 listed)
- Prior treatment with any agent targeting ROR1;
- Received anti-tumor therapy within 4 weeks prior to the start of treatment, including chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning);
- Presence of active central nervous system (CNS) metastasis;
- There is or has been a history of severe cardiovascular disease;
- There is an uncontrolled pleural, abdominal or pericardial effusion
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 |
|---|---|---|
| RD14-01Also: CAR-T infusionROR1 Targeted CAR-T cells | Biological | RD14-01 treated group |
Primary outcome
DLT and MTD
Time frame: up to 28 days after infusion
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
TEAEs
Time frame: up to 12 months after infusion
Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence
6 secondary outcomes
ORR
Time frame: up to 28 days after infusion
DOR
Time frame: up to 12 months after infusion
PFS
Time frame: up to 12 months after infusion
OS
Time frame: up to 12 months after infusion
Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
Time frame: up to 12 months after infusion
Persistence of RD14-01 CAR T cells in peripheral blood samples
Time frame: up to 12 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Sanbin Wang, Doctor principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RD14-01 in people with Solid Tumor, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
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 8 inclusion and 8 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sanbin Wang, Doctor ((+86)13187424131, Sanbin1011@163.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 after 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?
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 1 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.