ClinicalTrials.gg
Status unknownNCT03391726CCFRRBLUpdated Jan 5, 2018

CART-19 Cells for R/R B-cell Lymphoma

A Phase 2/3 interventional study of CART-19 cells in Relapsed or Refractory B-cell Lymphoma, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 1 Year to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-05.

Primary conditionLymphoma, B-CellRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, B-Cell
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Lymphoma, B-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fujian Medical University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2016, registered Dec 2017).
Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 65 Years
Sex
All
01

Study summary

Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

02

Conditions studied

  • Relapsed or Refractory B-cell Lymphoma

Browse trials for

03

In context

Lymphoma, B-Cell Reclassified

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.

Compared within Lymphoma, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
1 Year to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed written
  • Aged between 1-65 years
  • Patients with relapse/ B-cell lymphoma
  • Cardiac: ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: ≥ 70%

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CART-19 cells.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Arm 1

    CART-19 cells treat

    Other: CART-19 cells

Interventions

  • OtherCART-19 cells

    CART-19 cells treat

06

What researchers measure

Primary outcomes

  1. Disease-free survival

    Time frame: 1 year

Secondary outcomes

  1. Adverse events that are related to treatment

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03391726
Responsible party
Jianda Hu (Director of the department of Hematology, Fujian Medical University) — Principal investigator
First posted
Jan 5, 2018
Start date
Jan 1, 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 5, 2018

Study contacts

Jianda Hu, Prof.M.D.Ph.D
Contact
drjiandahu@163.com
86-13959169016

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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