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A Study of RD14-01 in Patients With Advanced Solid Tumors

Sponsor
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05748938
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: RD14-01
 Phase 1/Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors
Actual Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Aug 8, 2024
Anticipated Study Completion Date :
Feb 8, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: RD14-01 treated group

Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy.

Biological: RD14-01
ROR1 Targeted CAR-T cells
Other Names:
  • CAR-T infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. DLT and MTD [up to 28 days after infusion]

      Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

    2. TEAEs [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

    Secondary Outcome Measures

    1. ORR [up to 28 days after infusion]

      Overall Response Rate (ORR) by RECIST, version 1.1

    2. DOR [up to 12 months after infusion]

      Duration of response (DOR)

    3. PFS [up to 12 months after infusion]

      Progression Free Survival(PFS)

    4. OS [up to 12 months after infusion]

      Overall Survival (OS)

    5. Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples [up to 12 months after infusion]

      Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples

    6. Persistence of RD14-01 CAR T cells in peripheral blood samples [up to 12 months after infusion]

      Persistence of RD14-01 CAR T cells in peripheral blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥18 years old and < 70 years old, gender unlimited;

    2. Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology;

    3. Subjects who failed or were intolerant to standard treatment, or lacked effective treatment;

    4. ROR1+ by central laboratory immunohistochemistry (IHC);

    5. Adequate organ and marrow function;

    6. At least one measurable lesion as per RECIST v1.1;

    7. Estimated survival ≥3 months;

    7.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 8.Ability to understand and provide informed consent.

    Exclusion Criteria:

    1. Prior treatment with any agent targeting ROR1;

    2. Received anti-tumor therapy within 4 weeks prior to the start of treatment, including chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning);

    3. Presence of active central nervous system (CNS) metastasis;

    4. There is or has been a history of severe cardiovascular disease;

    5. There is an uncontrolled pleural, abdominal or pericardial effusion

    6. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis;

    7. Pregnant or breast-feeding females;

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Kunming Yunnan China 650000

    Sponsors and Collaborators

    • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    Investigators

    • Principal Investigator: Sanbin Wang, Doctor, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
    ClinicalTrials.gov Identifier:
    NCT05748938
    Other Study ID Numbers:
    • BHCT-RD14-01-02
    First Posted:
    Mar 1, 2023
    Last Update Posted:
    Mar 1, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
    Solid Tumor
    CAR-T Cell
    ROR1
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Mar 1, 2023