ClinicalTrials.gg
Status unknownNCT05619861Updated Nov 17, 2022

CAR-T Cells in the Treatment of Malignant Hematological Tumors

An interventional study of CAR-T in Lymphoma, B-Cell, Leukemia, B-cell and Leukemia, T-Cell, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Apr 2020, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 70 Years
Sex
All
01

Study summary

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Read the detailed description

Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

02

Conditions studied

  • Lymphoma, B-Cell
  • Leukemia, B-cell
  • Leukemia, T-Cell
  • Multiple Myeloma

Keywords

  • T cells
03

In context

Lymphoma, B-Cell

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

Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  1. With the consent of himself or the legal guardian and the signed , he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Hematopoietic and Lymphatic Tumor
  2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
  3. Age 14-70 (including boundary value), both male and female;
  4. Subjects with a physical status of 0\~2 in the American Eastern Oncology Collaboration Group ();
  5. The results of treatment related antigens were positive;
  6. The expected life span is more than 3 months from the date of signing the informed consent;
Terms in these criteria, in plain language(3)

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.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

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

Study arms

  • Experimental
    CAR-T

    Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg

    Biological: CAR-T

Interventions

  • BiologicalCAR-T

    Patients will receive CAR-T treatment

06

What researchers measure

Primary outcomes

  1. Safety: Incidence and severity of adverse events

    The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period

    Time frame: 24 months post CAR-T cells infusion

07

Study locations

1 of 1 sites recruiting
  • Cangzhou People's Hospital
    Cangzhou, Hebei, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2020 (actual). Primary completion is estimated for Jan 2023, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2022
First posted
Nov 17, 2022
StartActual
Apr 27, 2020
Primary completionEst.
Jan 26, 2023
CompletionEst.
Dec 26, 2023
Last update
Nov 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05619861
Collaborators
Cangzhou People's Hospital
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Apr 27, 2020
Primary completion
Jan 26, 2023 (estimated)
Completion
Dec 26, 2023 (estimated)
Last update
Nov 17, 2022

Oversight

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 Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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