WithdrawnEarly Phase 1

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

Stopped: Due to corporate strategic adjustment.

0Started 2025-10-10

Plain-language summary

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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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;
. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Limited Toxicity Rate

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

Incidence of Treatment-Emergent Adverse Events

Timeframe: Up to 24 months.

Trial details

NCT IDNCT07196111

SponsorGuangzhou Bio-gene Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-09

View on ClinicalTrials.gov More B Acute Lymphoblastic Leukemia/Lymphoma trials