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Status unknownNCT02782351Updated Aug 4, 2017

Humanized CAR-T Therapy for Treatment of B Cell Malignancy

A Phase 1/2 interventional study of CAR-T in Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Kai Lin Xu; Jun Nian Zheng. Status unknown at 2 sites in China. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Kai Lin Xu; Jun Nian Zheng · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
3 Years and older
Sex
All
01

Study summary

The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.

Read the detailed description

CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.

02

Conditions studied

  • Leukemia, Lymphocytic, Chronic, B-Cell
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Kai Lin Xu; Jun Nian Zheng is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
3 Years and older
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

  • Age≥3 at the time of consent
  • Survival time>12 weeks
  • B cell hematological malignancies by pathological examination
  • Chemotherapy failure or recurrent B cell malignancy
  • Creatinine\< 2.5mg/dl
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
  • Karnofsky Performance Status>50% at the time of screening
  • Bilirubin\<2.0mg/dl
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing women
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Previous treatment with any gene therapy product
  • Abnormal vital signs
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain.
  • Severe autoimmune diseases
  • other symptoms that are not applicable for CAR-T
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    CAR-T

    In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.

    Biological: CAR-T

Interventions

  • BiologicalCAR-T

    Patients will be infused with autologous CAR-T infusion in a dose escalating manner.

06

What researchers measure

Primary outcomes

  1. CAR-T cells persistence in peripheral blood

    The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR

    Time frame: 12 months

Secondary outcomes

  1. B cell number and immunoglobulins in peripheral blood

    The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
  • Huaian First People's Hospital
    Huai'an, Jiangsu 223300, China
    • Chunling Wang, M.D., Ph.D. · Contact
    Recruiting
  • Affiliated hospital of Xuzhou medical college
    Xuzhou, Jiangsu 221000, China
    • Jiang Cao, M.D., Ph.D. · Contact
    Recruiting
08

References and documents

Publications

  • van der Stegen SJ, Hamieh M, Sadelain M. The pharmacology of second-generation chimeric antigen receptors. Nat Rev Drug Discov. 2015 Jul;14(7):499-509. doi: 10.1038/nrd4597. PubMed 26129802 ↗
  • Davila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, Brentjens R. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol. 2014 Apr;99(4):361-71. doi: 10.1007/s12185-013-1479-5. Epub 2013 Dec 6. PubMed 24311149 ↗
  • Qi Y, Zhao M, Hu Y, Wang Y, Li P, Cao J, Shi M, Tan J, Zhang M, Xiao X, Xia J, Ma S, Qiao J, Yan Z, Li H, Pan B, Sang W, Li D, Li Z, Zhou J, Huang H, Liang A, Zheng J, Xu K. Efficacy and safety of CD19-specific CAR T cell-based therapy in B-cell acute lymphoblastic leukemia patients with CNSL. Blood. 2022 Jun 9;139(23):3376-3386. doi: 10.1182/blood.2021013733. PubMed 35338773 ↗
  • Chen W, Ma Y, Shen Z, Chen H, Ma R, Yan D, Shi M, Wang X, Song X, Sun C, Cao J, Cheng H, Zhu F, Sun H, Li D, Li Z, Zheng J, Xu K, Sang W. Humanized Anti-CD19 CAR-T Cell Therapy and Sequential Allogeneic Hematopoietic Stem Cell Transplantation Achieved Long-Term Survival in Refractory and Relapsed B Lymphocytic Leukemia: A Retrospective Study of CAR-T Cell Therapy. Front Immunol. 2021 Oct 29;12:755549. doi: 10.3389/fimmu.2021.755549. eCollection 2021. PubMed 34777367 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016, a primary completion of Jun 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

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

Registered
May 17, 2016
First posted
May 25, 2016
Start
May 2016
Primary completionEst.
Jun 2018
CompletionEst.
Dec 2018
Last update
Aug 4, 2017
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 Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02782351
Lead sponsor
Kai Lin Xu; Jun Nian Zheng
Collaborators
iCarTAB BioMed Inc., Huai'an First People's Hospital
Responsible party
Kai Lin Xu; Jun Nian Zheng (President, Xuzhou Medical University) — Sponsor-investigator
First posted
May 25, 2016
Start date
May 2016
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 4, 2017

Study contacts

Jiang Cao, M.D., Ph.D.
Contact
zimu05067@163.com
8651685802291
JunNian Zheng, M.D., Ph.D.
Contact
KaiLin Xu, MD. Ph.D.
principal investigator · Xuzhou Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Kai Lin Xu; Jun Nian Zheng

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