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Large B-cell LymphomaPhase 2NCT07236151

Sequential CD19/CD22 CAR-T Cell Therapy Following ASCT

A Phase 2 study testing Apheresis and Bridging Therapy, Conditioning and Stem Cell Transplantation and CAR-T Cell Administration in people with Large B-cell Lymphoma and CAR T Cell Therapy, 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
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Trial summary

The goal of this clinical trial is to learn if sequential CD19/CD22 CAR-T cell therapy following autologous stem cell transplantation (ASCT) works to treat relapsed or refractory large B-cell lymphoma (LBCL) in adults. It will also learn about the safety of this treatment combination. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Apheresis and Bridging Therapy, Conditioning and Stem Cell Transplantation and CAR-T Cell Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
24 Feb 2020to 30 Apr 2025
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy.
  • [Note: LBCL includes: diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); diffuse large B-cell lymphoma transformed from follicular lymphoma (FL-DLBCL); grade 3b follicular lymphoma (FL); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma with rearrangements of MYC and BCL-2 and/or BCL-6 (double-hit/triple-hit lymphoma, DHL/THL)].
  • Age Restriction: Individuals must be 18 to 70 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Presence of at least one measurable target lesion. *[Note: A target lesion is defined as ≥1 lesion with a longest diameter (LD) >1.5 cm and a longest perpendicular diameter (LPD) ≥1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).]*
  • Adequate organ function, defined as:
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  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiography;
  • Creatinine clearance ≥30 mL/min;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN).
  • Adequate hematopoietic function, defined as:
  • Platelet count ≥45 ×10⁹/L;
  • Hemoglobin ≥8.0 g/dL;
  • Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L.
  • Life expectancy ≥3 months.
  • For women of childbearing potential, a negative pregnancy test is required. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter.
  • Willingness to provide written informed consent.

Who cannot join

  • Prior allogeneic hematopoietic stem cell transplantation or CAR-T cell therapy.
  • Use of immunosuppressive agents or systemic corticosteroids (equivalent to >10 mg prednisone daily) within 2 weeks prior to leukapheresis, or requirement for continued use after enrollment.
  • Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (anti-HCV positive with detectable HCV RNA) infection at screening.
  • Uncontrolled active infection requiring intravenous antimicrobial therapy.
  • History of other malignancies within 2 years prior to enrollment (except adequately treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ).
  • Significant comorbidities that may compromise study participation or patient safety, including:
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  • Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, unstable arrhythmias, or angina)
  • Severe pulmonary dysfunction (FEV1 or DLCO ≤50% predicted, or requiring supplemental oxygen)
  • HIV infection (positive serology with detectable viral load).
  • Pregnancy, lactation, or unwillingness to use effective contraception.
  • Any condition that in the investigator's judgment would preclude safe participation.

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: A Clinical Study of Sequential CD19/CD22 CAR-T Cell Therapy Following Autologous Stem Cell Transplantation in Relapsed/Refractory Large B-cell Lymphoma

The goal of this clinical trial is to learn if sequential CD19/CD22 CAR-T cell therapy following autologous stem cell transplantation (ASCT) works to treat relapsed or refractory large B-cell lymphoma (LBCL) in adults. It will also learn about the safety of this treatment combination. The main questions it aims to answer are:

Does ASCT followed by sequential CD19/CD22 CAR-T therapy improve complete response rates in participants with relapsed/refractory LBCL? What medical problems do participants have when receiving this treatment combination? Researchers will evaluate the safety and efficacy of ASCT followed by sequential CD19/CD22 CAR-T therapy to determine if this treatment approach works to improve outcomes for patients with relapsed/refractory LBCL.

Read more

Participants will:

Undergo two separate apheresis procedures for stem cell collection and CAR-T cell manufacturing.

Receive conditioning chemotherapy followed by autologous stem cell infusion on day 0.

Receive sequential CD19 and CD22 CAR-T cell infusions over 3 days within one week post-transplant.Visit the clinic regularly for checkups and tests to monitor their response to treatment and any potential side effects.

Keep a record of their symptoms and any adverse events experienced during the treatment period.

Being tested
Apheresis and Bridging Therapy, Conditioning and Stem Cell Transplantation, CAR-T Cell Administration

What participants receive

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

  • Apheresis and Bridging TherapyOther

    Also called 1

    Patients undergo two separate apheresis procedures:

    • Mobilization and collection of autologous hematopoietic stem cells (HSCs) .
    • Collection of peripheral blood mononuclear cells (PBMCs) for the manufacture of CD19 and CD22 CAR-T cell products.

    Bridging therapy may be administered at the investigator's discretion between apheresis and the conditioning regimen.

  • Conditioning and Stem Cell TransplantationOther

    Also called 2

    Patients undergo a myeloablative conditioning regimen, followed by the infusion of autologous hematopoietic stem cells on Day 0.

  • CAR-T Cell AdministrationOther

    Also called 3

    Fractionated infusions of CD19-directed and CD22-directed CAR-T cells are completed within one week after HSC infusion.

Study groups in NCT07236151
Study groupRoleWhat they receive
ASCT+ CD19/CD22 CAR-TExperimentalNot described
Receives: Other: Apheresis and Bridging Therapy; Other: Conditioning and Stem Cell Transplantation; Other: CAR-T Cell Administration

What is being measured

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

  1. Best Complete Response Rate

    Best Complete Response Rate (CRR), defined as the proportion of patients achieving a best response of complete response according to the Lugano 2014 criteria.

    Measured: From the date of CAR-T cell infusion until the end of the study, with an average follow-up period of approximately 2 years.

Secondary outcomes (4)

  1. Overall survival

    Measured: From the date of CAR-T cell infusion until the date of death or last follow-up, assessed up to 5 years.

  2. Event-free survival

    Measured: From the date of CAR-T cell infusion to the date of first event (disease progression, relapse, or death) or last follow-up, assessed up to 5 years.

  3. Adverse event

    Measured: Within 30 days after CAR-T cell infusion

  4. Best Overall Response Rate

    Best Overall Response Rate (ORR), defined as the proportion of patients achieving a best response of complete response (CR) or partial response (PR) according to the Lugano 2014 criteria.

    Measured: From the date of CAR-T cell infusion until the end of the study, with an average follow-up period of approximately 2 years.

Timeline

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

  1. First posted19 Nov 2025
  2. Study start24 Feb 2020
  3. Primary completion21 Sep 2023
  4. Study completion30 Apr 2025

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07236151
Sponsor's protocol ID
ASCT+CD19/22 CART
Status last verified
Nov 2025
First submitted
26 Sep 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apheresis and Bridging Therapy, Conditioning and Stem Cell Transplantation and CAR-T Cell Administration in people with Large B-cell Lymphoma and CAR T Cell Therapy, 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 16 inclusion and 11 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 19 Nov 2025. 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?

Best Complete Response Rate (time frame: From the date of CAR-T cell infusion until the end of the study, with an average follow-up period of approximately 2 years.). 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 NCT07236151.

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 19 Nov 2025.

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