NCT05528887

Brief Summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
1mo left

Started Sep 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress99%
Sep 2021Jun 2026

Study Start

First participant enrolled

September 16, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

2.7 years

First QC Date

September 1, 2022

Last Update Submit

September 1, 2022

Conditions

Relapsed/Refractory Hematological MalignanciesLymphomaMyelomaLeukemia

Keywords

CD19 CAR-TBCMA CAR-TCD7 CAR-TCD123 CAR-T

Outcome Measures

Primary Outcomes (3)

  • TEAEs

    Incidence and severity of Treatment Emergent Adverse Event.

    4 weeks

  • TRAEs

    Incidence and severity of Treatment Related Adverse Events.

    4 weeks

  • AESIs

    Incidence and severity of AEs of Special Interest.

    4 weeks

Secondary Outcomes (3)

  • Objective Response Rate (ORR) (PR+CR)

    12 months

  • Progression-Free Survival (PFS)

    12 months

  • Overall survival (OS)

    12 months

Study Arms (1)

Autologous CAR-T cells

EXPERIMENTAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.

Biological: Autologous CAR-T cellsDrug: FludarabineDrug: Cyclophosphamide

Interventions

Autologous CAR-T cellsBIOLOGICAL

D0: CAR-T cells will be infused intravenously.

Autologous CAR-T cells
FludarabineDRUG

D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.

Also known as: Fludara
Autologous CAR-T cells
CyclophosphamideDRUG

D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.

Also known as: Cytoxan
Autologous CAR-T cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
  • Positive expression of specific antigens.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
  • Adequate organ functions:
  • Serum bilirubin ≤ 35 μmol/L;
  • Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2;
  • Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
  • Brain natriuretic peptide (BNP)\<80 pg/mL.
  • Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

You may not qualify if:

  • History of allergy to any of the drugs involved in the protocol.
  • History of cardiac diseases:
  • Left ventricular ejection fraction (LVEF) \< 50%;
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA).
  • History of another malignancy tumor.
  • Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
  • Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
  • Uncontrolled fungal, bacterial, viral, or other infection.
  • Female subjects who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, 315101, China

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsLymphomaNeoplasms, Plasma CellLeukemia

Interventions

fludarabinefludarabine phosphateCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Ying Lu

    The Affiliated People's Hospital of Ningbo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Lu

CONTACT

86-13486090834814871416@qq.com

Dong Chen

CONTACT

86-1380588808913805888089@163.com

Study Design

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

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

September 16, 2021

Primary Completion

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

CN(1)