UnknownPhase 1/2

A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects

China24 participantsStarted 2017-03-02

Plain-language summary

This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.

Who can participate

Age range

4 Years – 70 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: * Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled. * CD19+ leukemia or lymphoma * Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor * Follicular lymphoma, previously identified as CD19+: * Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc) * ECOG result is 0, 1 or 2. * With normal heart, liver and kidney functions. * Negative serum antibody for EBV, CMV, HBV, HCV, HIV and syphilis. * Negative in pregnancy test （female subject only). Exclusion Criteria: * ECOG result is 3, 4 or 5. * Pregnant or lactating women * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary * Previously treatment with any gene therapy products * HIV infection * Enrolled to other clinical study in the last 4 weeks. * Subjects with systemic auto-immune disease or immunodeficiency. * Subjects with CNS diseases. * Subjects with secondary tumors. * Subjects with tumor infiltration in liver, brain or GI tract.

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

Number of Participants With Adverse Events [Safety and Feasibility]

Timeframe: Study treatment until Week 24

Trial details

NCT IDNCT03156101

SponsorShenzhen BinDeBio Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-30

View on ClinicalTrials.gov More Relapsed B-cell Acute Lymphoblastic Leukemia trials