Trials Sponsors Conditions Drugs Pricing

Conditions

T-Acute Lymphoblastic Leukemia

Keywords

CD5 CAR-T

Outcome Measures

Primary Outcomes (2)

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Up to 28 days after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Up to 2 years after Treatment

Secondary Outcomes (4)

Overall response rate ,ORR
Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
Up to 1 years after CAR-T infusion
Progression Free Survival, PFS
Up to 2 years after Treatment
Overall survival, OS
Up to 1 years after CAR-T infusion

Study Arms (1)

Administration of CD5+ T-ALL Targeted CAR T-cells

EXPERIMENTAL

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Biological: CD5 CAR T-cells

Interventions

CD5 CAR T-cellsBiological

Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion

Also known as: CD5+ T-ALL Targeted CAR T-cells injection

Administration of CD5+ T-ALL Targeted CAR T-cells

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

Sponsors & Collaborators

Yake Biotechnology Ltd.
Industrycollaborator
Zhejiang University
Otherlead

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

He Huang, MDCONTACT057187233772 hehuangyu@126.com

Yongxian Hu, MDCONTACT057187233772 huyongxian2000@aliyun.com

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

He Huang, MD
First Affiliated Hospital of Zhejiang University
PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

057187233772 hehuangyu@126.com

Yongxian Hu, MD

CONTACT

057187233772

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Professor

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 9, 2024

Study Start

October 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

October 20, 2027

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Administration of CD5+ T-ALL Targeted CAR T-cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Administration of CD5+ T-ALL Targeted CAR T-cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations