Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed/Refractory Acute Myeloid Leukemia Relapsed/Refractory T-cell Lymphoma

Keywords

CD70CAR-NKT cell lymphomaacute myeloid leukemia

Outcome Measures

Primary Outcomes (2)

The incidence and type of dose-limiting toxicity (DLT) within 28 days
To determine the incidence and type of dose-limiting toxicity (DLT) within 28 days after CD70-CAR - NK cell infusion
28 days
the incidence and severity of treatment-related adverse events as assessed by CTCAE v4.0
CAR-NK treatment-related AEs include CRS, ICANS, cytopenia, and other non-hematological toxicities
within 90 days after CAR-NK infusion

Secondary Outcomes (3)

Objective response rate (ORR) at day 30
30 days
duration of response
2 years
progression-free survival
2 years

Other Outcomes (2)

CAR copies as assessed by qPCR
6 months
phenotypes of CAR-NK cells as assessed by flow cytometry
1 year

Study Arms (1)

CD70 CAR-NK for the treatment of CD70-positive relapsed/refractory T-cell lymphoma and AML

EXPERIMENTAL

The first stage is a dose escalation study, with three CD70 CAR-NK dose levels. Each dose level is planned to recruit 3 to 6 subjects to evaluate safety and efficacy and determine the number of CD70 CAR-NK cells for treatment in the second stage. The second stage is the dose expansion stage, where 30 subjects are recruited to receive the number of CD70 CAR-NK cells recommended in the first stage.

Biological: CD70 CAR-NK

Interventions

CD70 CAR-NKBiological

CAR - NK cells constructed by using genetic engineering technology retain the original extensive tumor - killing ability of NK cells. By using their unique target cell recognition mechanism, the target is accurately locked on specific antigen proteins, thereby enhancing the anti - tumor effect. Cord blood-derived CAR - NK cell products shorten the treatment time and are inexpensive. Multiple studies have confirmed the feasibility of CAR - NK cells in treating hematological tumors. Blocking the CD70/CD27 signaling pathway plays an important role in inhibiting CD70 - positive tumors, such as refractory/relapsed T - cell lymphoma and acute myeloid leukemia. Pre - clinical studies in our laboratory have proved that CD70 CAR - NK can effectively inhibit the in - vivo and in - vitro proliferation of T - cell lymphoma and prolong survival.

CD70 CAR-NK for the treatment of CD70-positive relapsed/refractory T-cell lymphoma and AML

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

According to the WHO disease classification, patients with relapsed/refractory T - lymphoma and acute myeloid leukemia:
Voluntarily participate in this study and sign the informed consent form;

Sponsors & Collaborators

Second Affiliated Hospital, Zhejiang University, School of Medicine
Otherlead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Yang XuCONTACT+86-571-87913679 yxu@zju.edu.cn

MeSH Terms

Conditions

Lymphoma, T-CellLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemiaHematologic Diseases

Central Study Contacts

Wenbin Qian

CONTACT

+86 0571 87783759 qianwb@zju.edu.cn

Yang Xu, Ph.D

CONTACT

yxu@zju.edu.cn

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

November 12, 2024

First Posted

November 20, 2024

Study Start

December 1, 2024

Actual (reported)

Primary Completion

November 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia

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 (3)

Other Outcomes (2)

Study Arms (1)

CD70 CAR-NK for the treatment of CD70-positive relapsed/refractory T-cell lymphoma and AML

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

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 (3)

Other Outcomes (2)

Study Arms (1)

CD70 CAR-NK for the treatment of CD70-positive relapsed/refractory T-cell lymphoma and AML

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations