NCT05277753

Brief Summary

The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T cells (CTLs) and immune modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negativity in T-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

2.8 years

First QC Date

February 21, 2022

Last Update Submit

March 14, 2022

Conditions

T-Cell Acute Lymphoblastic Leukemia

Keywords

T-ALLCAR TCTLDC vaccine

Outcome Measures

Primary Outcomes (3)

  • Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

    Safety of infusion

    1 year

  • Clinical response

    Leukemia blast cells are detected by multiparameter flow cytometry

    1 year

  • Evaluate the percentage of minimal leukemia residue in bone marrow

    Minimal leukemia residue（MRD）is measured by TCR next generation sequencing（NGS）.

    1 year

Study Arms (1)

CART/CTL/DCvac cells to treat T-ALL

EXPERIMENTAL
Biological: Antigen-specific T cells CAR-T/CTL and DCvac

Interventions

Antigen-specific T cells CAR-T/CTL and DCvacBIOLOGICAL

Antigen-specific T cells CAR-T/CTL and DCvac cells to treat T-ALL

CART/CTL/DCvac cells to treat T-ALL

Eligibility Criteria

Age6 Months - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 6 months.
  • High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL/DC vac preparation is required
  • Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1/2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.
  • Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0 mg/dL.
  • Hgb ≥ 80g/L.
  • No cell separation contraindications.
  • Abilities to understand and the willingness to provide written informed consent.

You may not qualify if:

  • Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
  • Active bacterial, fungal or viral infection not controlled by adequate treatment.
  • Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Pregnant or nursing women may not participate.
  • History of glucocorticoid for systemic therapy within the week prior to entering the test.
  • Previous treatment with any gene therapy products.
  • Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

S-1,2-dichlorovinyl-N-acetylcysteine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

86-0755-86725195c@szgimi.org

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 21, 2022

First Posted

March 14, 2022

Study Start

March 15, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

CN(1)