AzTrials
AzTrials

B Acute Lymphoblastic Leukemia/LymphomaEarly Phase 1NCT07196111

BAFFR CAR-T Treatment for Relapsed/Refractory B-cell Tumors

A Early Phase 1 study testing BAFFR CAR-T in people with B Acute Lymphoblastic Leukemia/Lymphoma, run by Guangzhou Bio-gene Technology Co., Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
B Acute Lymphoblastic Leukemia/Lymphoma
What is being tested?
BAFFR CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Oct 2025to 9 Dec 2028
Phase
Early Phase 1
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient or their guardian understands and voluntarily signs the informed consent form and expects to complete the follow-up examinations and treatments of the research protocol；
  • Age 18-85 years old (inclusive), gender unrestricted;
  • The definition of refractory in patients with B-cell lymphoma is as follows:
  • no response to the most recent treatment, including:
  • the best response to the most recent treatment regimen is disease progression (PD);
  • or the best response to the most recent treatment is stable disease (SD) and the duration does not exceed 6 months after the last administration;
Show all 14Show fewer
  • or unsuitable or unwilling to undergo autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including:
  • disease progression or recurrence within ≤ 12 months after ASCT;
  • or if salvage treatment is administered after ASCT, the subject must have no response or relapse after the last treatment;
  • B-ALL/LBL patients, refractory definition: failure to achieve complete remission (bone marrow blast cells ≥ 5% or persistence of extramedullary lesions) after standard induction or salvage therapy, or early relapse (<12 months) after remission with no response to re-induction therapy.
  • Patients with relapsed/refractory acute B-cell lymphoma who have previously been treated with anti-CD20 targeted agents (unless documented as CD20 negative) and anthracycline agents;
  • Patients with lymphoma must have at least one measurable lesion from baseline according to the revised IWG criteria for assessing the efficacy of malignant lymphoma；
  • The organ functions well；
  • ECOG performance status score 0-3 and estimated survival time greater than 3 months.

Who cannot join

  • Have other malignant tumors within 3 years before screening, excluding adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy.
  • Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
  • Those with a history of anaphylaxis [A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
  • Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.
  • Previous organ transplantation or preparation for organ transplantation (excluding hematopoietic stem cell transplantation).
  • Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
Show all 17Show fewer
  • Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.
  • Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.
  • Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.
  • Persons with severe mental illness.
  • Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .
  • Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.
  • hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.
  • Immunosuppressive agents: those who were receiving immunosuppressive agents within 2 weeks before PBMC collection.
  • Vaccination with live (attenuated) virus vaccine within 4 weeks prior to screening.
  • Alcoholics or those with a history of substance abuse.
  • Patients who, in the investigator's judgment and/or clinical criteria, have contraindications to any study procedure or other medical conditions that may put them at unacceptable risk.

About this study

Official title: Evaluation of the Safety and Efficacy of BAFFR CAR-T Therapy in Clinical Studies for Recurrent/Refractory B Cell Tumors.

This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion.

Read the detailed description

This study is a single-arm, mult-center clinical trial of dose escalation and dose expansion, primarily aimed at evaluating the safety, tolerability, and preliminary efficacy of BAFFR CAR-T cell infusion in subjects with relapsed/refractory B-cell tumors.

Being tested
BAFFR CAR-T
Keywords
BAFFR
Medical subject headings
Burkitt Lymphoma, Lymphoma

What participants receive

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

  • BAFFR CAR-TBiological

    A single infusion of BAFFR CAR-T Injection administered intravenously.

Study groups in NCT07196111
Study groupRoleWhat they receive
BAFFR CAR-T cell injectionExperimentalDose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of BAFFR CAR-T injection and to determine the MTD and/or the recommended phase II dose (RP2D). Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of BAFFR CAR-T injection, and to preliminarily evaluate its effectiveness.
Receives: Biological: BAFFR CAR-T

What is being measured

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

  1. Dose Limited Toxicity Rate

    After the infusion of CAR-T, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to CAR-T infusion after optimal supportive treatment.

    Measured: Up to 28 days after CAR-T infusion.

  2. Incidence of Treatment-Emergent Adverse Events

    Count the Incidence of adverse events.

    Measured: Up to 24 months.

Secondary outcomes (3)

  1. Concentration of CAR-T cells after Infusion (PK)

    CAR-T in peripheral blood after infusion

    Measured: Up to 24 months.

  2. overall response rate, ORR

    Defined as the proportion of subjects achieving complete response(CR), complete remission with incomplete blood cell recovery (CRi), or partial response(PR).

    Measured: Up to 24 months.

  3. Concentration of Cytokine after Infusion (PD)

    Calculate the change of cytokine concentration in peripheral blood after After CAR-T infusion. Cytokines include IL-2、IL-6 and so on.

    Measured: Up to 24 months.

Timeline

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

  1. First posted29 Sep 2025
  2. Study start10 Oct 2025 (estimated)
  3. Primary completion9 Oct 2028 (estimated)
  4. Study completion9 Dec 2028 (estimated)

Why it stopped: Due to corporate strategic adjustment.

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196111
Sponsor's protocol ID
YD-003
Status last verified
May 2026
First submitted
19 Sep 2025
Last updated
28 May 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 Early Phase 1 study testing BAFFR CAR-T in people with B Acute Lymphoblastic Leukemia/Lymphoma, run by Guangzhou Bio-gene Technology Co., Ltd.

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 14 inclusion and 17 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: withdrawn, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 was withdrawn before enrolling participants, so there are no results.

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?

Dose Limited Toxicity Rate (time frame: Up to 28 days after CAR-T infusion.). The study lists 2 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 NCT07196111.

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 28 May 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