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Status unknownNCT03528421Updated Jul 16, 2018

Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

A Phase 1 interventional study of IM19 and Fludarabine in Non Hodgkin Lymphoma, sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

Read the detailed description
  1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.
  2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.
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Conditions studied

  • Non Hodgkin Lymphoma

Keywords

  • CAR-T
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd. is the lead sponsor of 26 studies on the registry; 10 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
  2. Patients must have evaluable disease evidence;
  3. Age ≥ 18 years old;
  4. The expected life span is more than 3 months;
  5. ECOG score 0-2 points (see Attachment 2);
  6. Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up;
  7. Those who voluntarily participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria:

  1. Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
  2. Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
  3. Use chemotherapy or radiotherapy within 3 days before the blood collection period;
  4. Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
  5. Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
  6. Those who have previously used any gene therapy products;
  7. History of epilepsy or other diseases of the central nervous system;
  8. New York Heart Association (NYHA) class III or above (see Annex 3);
  9. creatinine> 1.5 times the upper limit of normal or ALT / AST> 3 times the upper limit of normal or bilirubin> 2 times the normal upper limit;
  10. active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
  11. pregnant or lactating women;
  12. suffer from other uncontrolled diseases that the researcher considers inappropriate;
  13. Any condition that the investigator believes may increase the subject's risk or interfere with the test results.
05

Study design

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

Study arms

  • Experimental
    IM19 CAR-T cells

    3\*10\^5/kg,1\*10\^6/kg,3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days

    Biological: IM19 · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

  • BiologicalIM19

    CAR-T cells

  • DrugFludarabine

    Two days before cell infusion, all patients will be treated with fludarabine for 3 days

  • DrugCyclophosphamide

    Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

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What researchers measure

Primary outcomes

  1. Occurrence of study related adverse events

    \>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

    Time frame: 2 years

Secondary outcomes

  1. Overall response rate

    (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing, China
    • Xinan Lu, Dr. · Contact
    • Jun Zhu · Principal investigator
    Recruiting
08

References and documents

Publications

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. PubMed 34515338 ↗
  • Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1. PubMed 33632155 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03528421
Lead sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute
Responsible party
Sponsor
First posted
May 17, 2018
Start date
May 22, 2018
Primary completion
Apr 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Jul 16, 2018

Study contacts

Xin-an Lu, Dr
Contact
luxinan@immunochina.com
86-189-1157-6946

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 May 2018. You cannot join it, but the record below documents what was studied.

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