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AzTrials

Hematopoietic/Lymphoid CancerPhase 1/2NCT03097770

Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20

A Phase 1/2 study testing anti-CD19/20-CAR vector-transduced T cells in people with Hematopoietic/Lymphoid Cancer and Adult Acute Lymphoblastic Leukemia in Remission, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Read more about this study

Who is it for?
Ages 16 to 70 years
What is being tested?
anti-CD19/20-CAR vector-transduced T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Apr 2017to 31 Jan 2020
Phase
Phase 1/2
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 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study have to meet all of the following criteria:
  • Age ≥18 and ≤70 years.
  • Performance status (ECOG) between 0 and 2.
  • Histologically confirmed CD20+ and/or CD19+ B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2008:
  • DLBCL not otherwise specified, DLBCL associated with chronic inflammation, and Epstein-Barr virus (EBV)+ DLBCL in the elderly.
  • Primary mediastinal (thymic) large B-cell lymphoma (PMBCL). The mediastinal mass had to have an axial diameter <5 cm or extranodal lesion size <3 cm. Patients with large lesions (≥5 cm) were enrolled in our other clinical trial (NCT0334662).
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  • Transformed FL (tFL) .
  • FL.
  • Some indolent lymphomas including MCL and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
  • Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT.
  • We defined chemotherapy-refractory disease as meeting one or more of the following criteria:
  • No response to first-line therapy (primary refractory disease).
  • No response to second-line or later therapy.
  • PD as the best response to the most recent therapy regimen.
  • Stable disease (SD) as the best response after at least 2 cycles of the most recent line of therapy with a SD duration of no longer than 6 months from the last dose of therapy.
  • Failure following autologous HSCT was defined as follows:
  • PD or relapsed disease ≤12 months after ASCT (requires biopsy-proven recurrence in relapsed subjects).
  • No response or relapse after salvage therapy is given post-ASCT.
  • PD or relapse ≥3 months after treatment with a targeted CD19 therapy, including CD19-CAR T cells or anti-CD19/anti-CD3.
  • Successful leukapheresis assessment and pre-culture of T cells.
  • Life expectancy > 3 months.
  • Adequate organ function:
  • Creatinine < 1.6 mg/dL (140 µmol/L) or creatinine clearance ≥60 mL/min.
  • ALT/AST < 3× upper limit of the normal range.
  • Bilirubin <2.0 mg/dL unless the subject had Gilbert's Syndrome (<3.0 mg/dL).
  • A minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnoea and pulse oxygenation > 91% with room air. No clinically significant pleural effusion.
  • Cardiac ejection fraction ≥50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.
  • An adequate bone marrow reserve defined as:
  • Absolute neutrophil count (ANC)>1,000/mm3.
  • Absolute lymphocyte count (ALC)≥300/mm3.
  • Platelet count ≥ 50,000/mm3.
  • Haemoglobin > 7.0 mg/dL.
  • Measurable or assessable disease according to the "IWG Response Criteria for Malignant Lymphoma" (Cheson 2007). Patients in CR with no evidence of disease were not eligible.
  • Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.

Who cannot join

  • Patients eligible for this study must not meet any of the following criteria:
  • Patients with definite involvement of gastrointestinal tract. Endoscopy should be performed to conform gastrointestinal involvement for patients suspected. However, patients with central nervous system (CNS) involvement were cautiously enrolled in this clinical study.
  • CD19 CAR T cell treatment failure or recurrence, detection of a clear HAMA effect, or negative tumour puncture detection of CD19 and CD20.
  • Pregnant or lactating women.
  • Uncontrolled active bacterial or viral infection. (active hepatitis B or hepatitis C infection, HIV infection) or treponema pallidum infection.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification and a cardiac ejection fraction ≥50%.
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  • History of allogeneic stem cell transplantation.
  • Any autoimmune disease or primary immunodeficiency.
  • Requirement for urgent therapy due to tumour mass effects such as respiratory obstruction or blood vessel compression.
  • Current or expected need for systemic corticosteroid therapy.
  • Any organ failure.
  • The patients with the second tumour requiring for therapy or intervention.
  • Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as overall response rate (ORR).

SECONDARY OBJECTIVES:

  1. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to response (TTR), duration of overall response (DOR), progression free survival (PFS) and overall survival (OS).

III. To determine in vivo expansion and persistence of TanCAR19/20 T cells.

OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on day1 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 3 years.

Being tested
anti-CD19/20-CAR vector-transduced T cells
Medical subject headings
Hematologic Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

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

  • anti-CD19/20-CAR vector-transduced T cellsBiological

    Also called genetically engineered lymphocyte therapy

    genetically engineered lymphocyte therapy

Study groups in NCT03097770
Study groupRoleWhat they receive
anti-CD19/20 CAR T cellsExperimentalPatients receive anti-CD19/20-CAR retroviral vector-transduced autologous or donor-derived T cells on day 1 in the absence of disease progression or unacceptable toxicity.
Receives: Biological: anti-CD19/20-CAR vector-transduced T cells

What is being measured

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

  1. Occurrence of study related adverse events

    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

    Measured: Until week 24

Secondary outcomes (1)

  1. Anti-tumor responses to tanCART19/20 cell infusions

    Measured: up to 96 weeks

Timeline

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

  1. First posted31 Mar 2017
  2. Study start1 Apr 2017
  3. Primary completion10 May 2019
  4. Study completion31 Jan 2020

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03097770
Sponsor's protocol ID
CHN-PLAGH-BT-020
Status last verified
Dec 2019
First submitted
26 Mar 2017
Last updated
2 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Han F, Zhong Y, Tong C, Wang C, Liu Y, Yang Q, Guo Y, Zhang Y, Wu Z, Han W, Wang Y. Five-Year Follow-Up: Tandem CD19/CD20 CAR T Therapy Enduring Impact on Refractory/Relapsed Non-Hodgkin Lymphoma. Am J Hematol. 2026 Jun;101(6):1226-1238. doi: 10.1002/ajh.70281. Epub 2026 Mar 9.

    PubMed 41804087

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing anti-CD19/20-CAR vector-transduced T cells in people with Hematopoietic/Lymphoid Cancer and Adult Acute Lymphoblastic Leukemia in Remission, run by Chinese PLA General Hospital 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 34 inclusion and 13 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: finished, as of the sponsor's last update on 2 Sep 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of study related adverse events (time frame: Until week 24). 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 NCT03097770, which also lists 2 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 2 Sep 2020.

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