AzTrials
AzTrials

Relapsed/Refractory B-cell Non-Hodgkin's LymphomaPhase 2NCT05322330

Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 2 study testing Selinexor, Flu and CTX in people with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Aim of this study will evaluate the Efficacy and Safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Selinexor, Flu and CTX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
10 Feb 2022to 10 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Pathological immunohistochemistry or flow cytometry confirmed that R/ R B-cell Non-Hodgkin's Lymphoma with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by <50%; 2> R/ R B-cell Non-Hodgkin's Lymphoma with disease progression after first-line or induction therapy; 3> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%.
  • Previously treated with 2 or more lines of therapy.
  • ECOG≤2#.
  • The main organ functions need to meet the following conditions:LVEF≥50%;CR≤132 umol/l or CCr≥60 ml/min; ALT and AST≤2.5 times normal range#TB≤2 times ULN#Lung function≤Level 1; dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 90%.
  • Pass the T-cell amplification test.
Show all 10Show fewer
  • Voluntary tissue puncture/biopsy for tumor tissue retrieval before and after treatment.
  • Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
  • Estimated survival time ≥3 months.
  • Voluntary signing of informed consent and good compliance.

Who cannot join

  • Have used immunosuppressants or hormones within 2 weeks prior to signing informed consent, or plan to have to use immunosuppressants or high-dose hormones (e.g. prednisone >15mg) after signing informed consent, specifically systemic treatment, excluding treatment with topical or inhaled corticosteroids.
  • The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
  • Active hepatitis B or active hepatitis C.
  • HIV infection.
  • Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form.
  • Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form.
Show all 12Show fewer
  • Received CAR-T cell therapy within 3 months prior to signing the informed consent form.
  • Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form.
  • Presence of contraindications to XPO-1 inhibitor.
  • Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ.
  • Pregnant or breasting-feeding women.
  • Conditions deemed by the researcher to be inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Clinical Study of the Efficacy and Safety of XPO-1 Inhibitors in Combination With CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma

Aim of this study will evaluate the Efficacy and Safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma

Read the detailed description

B-cell non-Hodgkin's lymphoma (B-NHL) is the most common hematological malignancy originating from lymphohematopoietic tissue. Lymphoma is now one of the most rapidly growing malignancies worldwide, with approximately 350,000 new cases and over 200,000 deaths worldwide each year.With the use of rituximab in combination with standard chemotherapy regimens, progression-free survival (PFS) and overall survival (OS) in B-NHL have improved significantly, yet primary resistance or relapse progression still occurs in 40%-50% of B-NHL patients.The most widely used CAR-T therapy for R/R B-NHL in clinical practice is CAR-T therapy targeting CD19, which has a complete remission rate (CR) of 40%-53% and an overall remission rate (ORR) of 52%-82%.XPO1 inhibitors are potential drugs to enhance the anti-lymphoma effect of CD19 CAR-T cells, this study will evaluate the efficacy and safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma.

Being tested
Selinexor, Flu, CTX, CAR-T
Keywords
XPO-1 Inhibitor, CAR-T Cells, Relapsed Refractory B-cell Non-Hodgkin's Lymphoma
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called XPO-1 Inhibitor

    40-60mg QW,w-3～d-3,PO

  • FluDrug

    Also called Fludarabine

    25-30 mg/m2，d-5 ～d-3，qd，ivgtt

  • CTXDrug

    Also called Cyclophosphamide

    250-500 mg/m2，d-5 ～d-3，qd，ivgtt

  • CAR-TDrug

    Also called Chimeric antigen receptor-modified T (CAR-T) cell therapy

    2-5×10^6 CAR-T/kg，ivgtt。

Study groups in NCT05322330
Study groupRoleWhat they receive
XPO-1 Inhibitor+CAR-T CellsExperimentalXPO-1 Inhibitor plus CAR-T Cells
Receives: Drug: Selinexor; Drug: Flu; Drug: CTX; Drug: CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    To measure the duration of response to XPO-1 Inhibitor Plus CAR-T Cells over a follow-up period of 12 months

    Measured: up to 12 months

  2. Duration of Response(DOR) Duration of Response(DOR)

    Duration of overall response will be assessed from the first XPO-1 Inhibitor Plus CAR-T cells given to progression,death or last follow-up.

    Measured: up to 12 months

  3. Adverse events profile

    Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.

    Measured: up to 12 months

Secondary outcomes (6)

  1. Complete Response Rate

    Number of patients who achieved complete response after treatment by XPO-1 Inhibitor plus CAR-T cells.

    Measured: up to 12 months

  2. Progression-free Survival

    To measure the duration of response to XPO-1 Inhibitor plus CAR-T cells over a follow-up period of 12 months.

    Measured: up to 12 months

  3. Overall Survival

    OS will be assessed from the first XPO-1 Inhibitor plus CAR-T cells given to death or last follow-up.

    Measured: up to 12 months

  4. Peak Plasma Concentration

    the peak amplification of CART in peripheral blood.

    Measured: Measured from start of treatment until 28 days after last dose

  5. Time to Peak Amplification

    The time to peak amplification of CART in peripheral blood.

    Measured: Measured from start of treatment until 28 days after last dose

  6. AUC0-28

    The area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion.

    Measured: Measured from start of treatment until 28 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start10 Feb 2022
  3. Primary completion10 Feb 2024
  4. Study completion10 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05322330
Sponsor's protocol ID
R/R B-NHL 01
Status last verified
Mar 2022
First submitted
21 Mar 2022
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Flu and CTX in people with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05322330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in