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CD19-positive ALLPhase 1NCT04303520

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL

A Phase 1 study testing anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide in people with CD19-positive ALL, run by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia. Read more about this study

Who is it for?
Ages 13 to 70 years
Conditions the study is for
CD19-positive ALL
What is being tested?
anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
3 May 2018to Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 13 Years to 70 Years, Male and female;
  • Expected survival > 12 weeks;
  • Clinical performance status of ECOG score 0-2;
  • Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:
  • Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
  • Disease recurrence after stem cell transplantation.
Show all 14Show fewer
  • Accessible to intravenous injection, and no white blood cell collection contraindications
  • Patients who meet the following conditions:
  • Creatinine < 2.5 mmol/l;
  • Cardiac ejection fraction>50%, no pericardial effusion and no pleural effusion (ECHO examination);
  • Baseline oxygen saturation>92%;
  • Total bilirubin≤1.5xULN;
  • ALT/AST≤2.5x normal.
  • Able to understand and sign the Informed Consent Document.

Who cannot join

  • Accompanied by other malignant tumor
  • Active hepatitis B, hepatitis C, syphilis, HIV infection
  • Suffering severe cardiovascular or respiratory disease
  • Any other diseases could affect the outcome of this trial
  • Any affairs could affect the safety of the subjects or outcome of this trial
  • Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
Show all 11Show fewer
  • Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
  • Patients who are accounted by researchers to be not appropriate for this test
  • Received CAR-T treatment or other gene therapies before assignment
  • Patients with symptoms of central nervous system
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Henan Province of TCM

    Zhengzhou, Henan

    Zhi Cheng, M.D., +(86)-139-3852-6995, clinicaltrials.chengzhi@outlook.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.

Read the detailed description

Primary Objectives

  1. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia.

Secondary Objectives

  1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells.
  2. To determine in vivo expression of CD19-positive B cells.
  3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion.
  4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.
Being tested
anti-CD19/CD22 CAR-T cells, Fludarabine, Cyclophosphamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD19/CD22 CAR-T cellsBiological

    Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs

  • FludarabineDrug

    30mg/m2/d

  • CyclophosphamideDrug

    500mg/m2/d

Study groups in NCT04303520
Study groupRoleWhat they receive
anti-CD19/CD22 CAR-T cellsExperimentalAdministration with anti-CD19/CD22 CAR-T cells in the CD19-positive ALL patients
Receives: Biological: anti-CD19/CD22 CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    Measured: 6 months

Secondary outcomes (3)

  1. Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

    Measured: 8 weeks

  2. Duration of CAR-positive T cells in circulation

    Duration of CAR-positive T cells in circulation

    Measured: 6 months

  3. Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start3 May 2018
  3. Primary completionSep 2020 (estimated)
  4. Study completionFeb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303520
Sponsor's protocol ID
Anti-CD19/CD22 CAR-T
Status last verified
Mar 2020
First submitted
9 Mar 2020
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Litzow MR. Hematology clinic. Acute lymphoblastic leukemia. Hematology. 2014 Jun;19(4):246-7. doi: 10.1179/1024533214Z.000000000281. No abstract available.

    PubMed 24856441

  • Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.

    PubMed 22493293

  • Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995 Dec 7;333(23):1540-5. doi: 10.1056/NEJM199512073332305.

    PubMed 7477169

  • Nguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25.

    PubMed 18818707

  • Bhojwani D, Pui CH. Relapsed childhood acute lymphoblastic leukaemia. Lancet Oncol. 2013 May;14(6):e205-17. doi: 10.1016/S1470-2045(12)70580-6.

    PubMed 23639321

  • Raetz EA, Bhatla T. Where do we stand in the treatment of relapsed acute lymphoblastic leukemia? Hematology Am Soc Hematol Educ Program. 2012;2012:129-36. doi: 10.1182/asheducation-2012.1.129.

    PubMed 23233571

  • Uckun FM, Jaszcz W, Ambrus JL, Fauci AS, Gajl-Peczalska K, Song CW, Wick MR, Myers DE, Waddick K, Ledbetter JA. Detailed studies on expression and function of CD19 surface determinant by using B43 monoclonal antibody and the clinical potential of anti-CD19 immunotoxins. Blood. 1988 Jan;71(1):13-29.

    PubMed 3257143

  • Onea AS, Jazirehi AR. CD19 chimeric antigen receptor (CD19 CAR)-redirected adoptive T-cell immunotherapy for the treatment of relapsed or refractory B-cell Non-Hodgkin's Lymphomas. Am J Cancer Res. 2016 Jan 15;6(2):403-24. eCollection 2016.

    PubMed 27186412

  • Ramos CA, Heslop HE, Brenner MK. CAR-T Cell Therapy for Lymphoma. Annu Rev Med. 2016;67:165-83. doi: 10.1146/annurev-med-051914-021702. Epub 2015 Aug 26.

    PubMed 26332003

  • Gardner RA, Finney O, Annesley C, Brakke H, Summers C, Leger K, Bleakley M, Brown C, Mgebroff S, Kelly-Spratt KS, Hoglund V, Lindgren C, Oron AP, Li D, Riddell SR, Park JR, Jensen MC. Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults. Blood. 2017 Jun 22;129(25):3322-3331. doi: 10.1182/blood-2017-02-769208. Epub 2017 Apr 13.

    PubMed 28408462

  • Turtle CJ, Hanafi LA, Berger C, Gooley TA, Cherian S, Hudecek M, Sommermeyer D, Melville K, Pender B, Budiarto TM, Robinson E, Steevens NN, Chaney C, Soma L, Chen X, Yeung C, Wood B, Li D, Cao J, Heimfeld S, Jensen MC, Riddell SR, Maloney DG. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest. 2016 Jun 1;126(6):2123-38. doi: 10.1172/JCI85309. Epub 2016 Apr 25.

    PubMed 27111235

  • Park JH, Geyer MB, Brentjens RJ. CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date. Blood. 2016 Jun 30;127(26):3312-20. doi: 10.1182/blood-2016-02-629063. Epub 2016 May 20.

    PubMed 27207800

  • Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.

    PubMed 25319501

  • Ma Q, Wei R, Wang Q, Jiang S, Wu Y, Min C, Guo S, Zhang Y, Sun X, Wu H, Sun X, Xiang F, Xiao M, Cheng Z. A bi-specific CAR-T cell therapy targeting CD19 and CD22 in relapsed or refractory B-ALL. Clin Exp Med. 2025 Jul 28;25(1):264. doi: 10.1007/s10238-025-01637-8.

    PubMed 40719826

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide in people with CD19-positive ALL, run by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04303520, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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