CompletedPhase 1

Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

China9 participantsStarted 2019-11-05

Plain-language summary

This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.

Who can participate

Age range

3 Years – 21 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

. Diagnosed with B-ALL，and meet one of the following conditions:
. First-line or multiple-line salvage chemotherapy did not achieve complete remission；
. Early relapse after complete remission (\<12 months), or late relapse after complete remission (≥12 months) and complete remission has not been achieved after 1 course of treatment；
. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
. Ph+ALL patients should also receive at least two TKI treatments；
. For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
. Allo-HSCT takes ≥6 months before pCAR-19B infusion；

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

Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability]

Timeframe: 28 days

Obtain the maximum tolerated dose of pCAR-19B cells[Safety and Tolerability]

Timeframe: 28 days

Trial details

NCT IDNCT04888468

SponsorChongqing Precision Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-29

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Who can participate

Age range

3 Years – 21 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

. Diagnosed with B-ALL，and meet one of the following conditions:
. First-line or multiple-line salvage chemotherapy did not achieve complete remission；
. Early relapse after complete remission (\<12 months), or late relapse after complete remission (≥12 months) and complete remission has not been achieved after 1 course of treatment；
. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
. Ph+ALL patients should also receive at least two TKI treatments；
. For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
. Allo-HSCT takes ≥6 months before pCAR-19B infusion；

Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria