Suspended

Anti-CD19 CAR NK Cell Therapy for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma: a Multi-center, Uncontrolled Trial.

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What is being tested

anti-CD19 CAR NK

Biological
Who is being recruted

From 18 to 75 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: December 2020
See protocol details

Summary

Principal SponsorXinqiao Hospital of Chongqing
Study ContactXi Zhang, MD phDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 17, 2020

Actual date on which the first participant was enrolled.

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. therefore, we designed this trial to manifest the safety and efficacy of anti-CD19 CAR NK cell therapy in non-Hodgkin lymphoma

Official TitleAnti-CD19 CAR NK Cell Therapy for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma: a Multi-center, Uncontrolled Trial.
NCT04639739
Principal SponsorXinqiao Hospital of Chongqing
Study ContactXi Zhang, MD phDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

19 inclusion criteria required to participate
Male or female subjects between the ages of 18 and 75 (including critical values)
Subjects histologically confirmed as diffuse diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), primary mediastinal B cell lymphoma (PMBCL) and mantle cell lymphoma (MCL)
Subjects with TFL must receive chemotherapy before transformation and meet the definition of relapse or refractory after transformation
According to Lugano response criteria 2014, there should be at least one evaluable tumor focus: the longest diameter of intranodal focus > 1.5cm, the longest diameter of extranodal focus > 1.0cm
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18 exclusion criteria prevent from participating
Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years
Severe mental disorders
A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome
History of allogeneic stem cell transplantation
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determined optimal dosage.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Hematology, Xinqiao Hospital

Chongqing, ChinaOpen Department of Hematology, Xinqiao Hospital in Google Maps
SuspendedOne Study Center