NCT05748938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 8, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

February 15, 2023

Last Update Submit

February 18, 2023

Conditions

Solid Tumor

Keywords

Solid TumorCAR-T CellROR1

Outcome Measures

Primary Outcomes (2)

  • DLT and MTD

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

    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

    up to 12 months after infusion

Secondary Outcomes (6)

  • ORR

    up to 28 days after infusion

  • DOR

    up to 12 months after infusion

  • PFS

    up to 12 months after infusion

  • OS

    up to 12 months after infusion

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

    up to 12 months after infusion

  • +1 more secondary outcomes

Study Arms (1)

RD14-01 treated group

EXPERIMENTAL

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

Biological: RD14-01

Interventions

RD14-01BIOLOGICAL

ROR1 Targeted CAR-T cells

Also known as: CAR-T infusion
RD14-01 treated group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Sanbin Wang, Doctor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, Doctor

CONTACT

(+86)13187424131Sanbin1011@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 1, 2023

Study Start

February 8, 2023

Primary Completion

August 8, 2024

Study Completion

February 8, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

CN(1)