Trials Sponsors Conditions Drugs Pricing

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (4)

Dose limited toxicity (DLT) (phase 1)
DLT is defined as any of the following adverse events (AEs) related to BEX101 injection infusion occurring within 28 days after BEX101 injection infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0): * Grade ≥ 3 neurotoxicity and/or CRS that does not resolve to Grade ≤ 2 within 7 days after therapeutic intervention; * Grade ≥ 3 non-hematologic toxicities other than CRS and neurotoxicity that do not resolve to Grade ≤ 2 within 14 days despite appropriate clinical treatment and management, excluding clinically insignificant laboratory abnormalities; * Grade ≥ 4 hematologic toxicities, including decreased neutrophil count and decreased platelet count, persisting for \> 28 days after infusion of BEX101 injection.
Within 28 days post-infusion
Incidence and severity of AEs and serious AEs (SAEs) (phase 1)
AEs refer to any adverse medical events occurring in subjects from the initiation of BEX101 administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after BEX101 administration in subjects.
Within 24 months post-infusion
Incidence and severity of AEs of special interest (AESI) (phase 1)
AESI including grade ≥ 3 CRS, ICANS, and infections
Within 24 months post-infusion
Objective Response Rate (ORR) (phase 2)
ORR includes CR and PR.
Within 24 months post-infusion

Secondary Outcomes (9)

Incidence and severity of AEs (phase 2)
Within 24 months post-infusion
ORR (phase 1)
Within 24 months post-infusion
Duration of Response (DOR) (phase 1 and phase 2)
Within 24 months post-infusion
Progression-Free Survival (PFS) (phase 1 and phase 2)
Within 24 months post-infusion
Overall Survival (OS) (phase 1 and phase 2)
Within 24 months post-infusion
+4 more secondary outcomes

Other Outcomes (5)

Infiltration of CAR-T cells (phase 1 and phase 2)
Within 3 months post-infusion
Characteristics of the edited T cells and their in vivo evolutionary dynamics after infusion (phase 1 and phase 2)
Within 24 months post-infusion
Correlation between subjects' baseline T-cell characteristics and CAR-T expansion and treatment response (phase 1 and phase 2)
Within 24 months post-infusion
+2 more other outcomes

Study Arms (1)

Experimental: BEX101 injection

EXPERIMENTAL

Administered by IV infusion

Biological: BEX101 injection

Interventions

BEX101 injectionBiological

BEX101 injection is an extracorporeal anti-CD19 CAR-T cell therapy product.

Experimental: BEX101 injection

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:

Age 18 to 75 years (inclusive), regardless of sex.
Subjects who meet the following diagnostic and treatment requirements:

Sponsors & Collaborators

Chinese PLA General Hospital
Otherlead

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Weidong Han, M.D.CONTACT+86-010-66939460 hanwdrsw@sina.com

Yang Liu, M.D.SUB INVESTIGATOR

Jinhong Shi, M.Med.SUB INVESTIGATOR

Qin Wang, M.Med.SUB INVESTIGATOR

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Weidong Han, M.D.

CONTACT

+86-010-66939460 hanwdrsw@sina.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor and Chief Physician

Study Record Dates

First Submitted

October 12, 2026

First Posted

October 20, 2026

Study Start

October 15, 2026

Estimated (date passed)

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

Primary Completion

October 30, 2028

You may not qualify if:

Estimated life expectancy \< 3 months.
History of or concurrent active malignancy. Exceptions include curatively treated carcinoma in situ of the cervix, noninvasive basal cell or squamous cell skin cancer, locally confined prostate cancer after definitive treatment, or ductal carcinoma in situ after curative surgery, provided there has been no recurrence for at least 3 years;
Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months prior to planned infusion of BEX101 injection.
History of central nervous system (CNS) disease or presence of clinically significant CNS dysfunction, such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, epilepsy, aphasia, or other similar conditions.
Myocardial infarction, cardiac angioplasty or stent implantation, unstable angina, or other clinically significant cardiac disease within 12 months prior to screening.
Lymphoma involvement of the atrium or ventricle.
Presence of CNS metastases or symptoms suggestive of CNS metastases.
Ongoing or anticipated tumor-related emergency requiring treatment within 6 weeks after signing the informed consent form, such as mass effect from tumor bulk or tumor lysis syndrome.
Prior antitumor therapy for which the washout period has not exceeded 5 half-lives before the planned infusion of BEX101 injection.
Use of any of the following drugs or treatments within the specified time periods.
Radiotherapy within 8 weeks prior to administration of the investigational product (except prophylactic treatment for CNS involvement).
Alemtuzumab within 6 months prior to administration of the investigational product, or fludarabine or bendamustine within 3 months prior to administration.
Other cytotoxic drug therapy within 2 weeks prior to administration of the investigational product.
Corticosteroids or immunosuppressive therapy within 1 week prior to administration of the investigational product.
Monoclonal antibody therapy within 3 weeks prior to administration of the investigational product.
+10 more criteria

BEX101 in B-cell Non-Hodgkin's Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (9)

Other Outcomes (5)

Study Arms (1)

Experimental: BEX101 injection

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:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (9)

Other Outcomes (5)

Study Arms (1)

Experimental: BEX101 injection

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:

Source record

Locations