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Non-hodgkin's LymphomaNCT04666168

A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma

A study testing Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis in people with Non-hodgkin's Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL)… Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Non-hodgkin's Lymphoma
What is being tested?
Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
22 Oct 2020to 21 Oct 2025
Phase
Interventional
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study specified in the test flow sheet; 2. Patients with hematopoiesis and lymphoid tissue tumors diagnosed as relapsed and refractory by clinical diagnosis were defined as relapse or refractory
  • Primary drug resistance to standard treatment regimen;
  • Or PD occurred after at least second-line standard treatment;
  • Or the last treatment effect was SD and lasted no more than 6 months;
  • Or CD20 positive patients were ineffective or relapsed after anti-CD20 mAb treatment;
  • Or PD after autologous hematopoietic stem cell transplantation, or recurrence confirmed by biopsy within 12 months, or salvage treatment after autologous hematopoietic stem cell transplantation has no remission or recurrence after treatment.
  • 3. According to RECIST version 1.1 , there should be at least one measurable tumor focus; 4. Subjects with ECoG score of 0-2 5. 14 years old ≤ age ≤ 75 years old, both male and female; 6. The tumor cells were positive for CD19 or CD22 / CD30 / CD7 / CD79 by immunohistochemistry or flow cytometry; 7. The expected survival time is more than 3 months from the date of signing the informed consent； 8. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 10^9/L, absolute neutrophil count (ANC) ≥1.0 × 10^9/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor; 9. The main organ function indicators meet the following conditions: AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher than level 1 and blood oxygen saturation> 92% under indoor conditions).

Who cannot join

  • Severe cardiac insufficiency, left ventricular ejection fraction <50%;
  • There is a history of severe lung dysfunction diseases;
  • The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
  • Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
  • Combined metabolic diseases (except diabetes);
  • Combined with severe autoimmune disease or innate immune deficiency;
Show all 11Show fewer
  • Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [ HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and C co-infection;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
  • A history of severe allergies to biological products (including antibiotics);
  • Participate in any other clinical drug trials at the same time within one month;
  • There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.

Trial locations and contacts

1 site in 1 country.

Jianqiang Li, PhD & MD contact

008615511369555

limmune@gmail.com

China1 site, 1 recruiting

  • Hematology Department, Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei, 050000

    Lihong Liu, PhD & MD, +8613831177920, limmune@gmail.com

    Baoen Shan, PhD & MD

    Recruiting

Other trials in China

About this study

This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL), high-grade B-cell lymphoma, etc; Invasive NHL includes diffuse large B-cell lymphoma, mantle cell lymphoma and peripheral T-cell lymphoma; Inert NHL contains follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

Read the detailed description

A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Being tested
Auto CAR-T, Cyclophosphamide,Fludarabine, Leukapheresis
Keywords
NHL
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • Auto CAR-TBiological

    Biological: Auto CAR-T

  • Cyclophosphamide,FludarabineDrug

    Drug: Cyclophosphamide,Fludarabine

  • LeukapheresisProcedure or surgery

    Leukapheresis

Study groups in NCT04666168
Study groupRoleWhat they receive
Auto CAR-TExperimentalPatients will be treated with Auto CAR-T cells
Receives: Biological: Auto CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

What is being measured

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

  1. Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    Measured: first one month after CAR-T infusion

  2. Efficacy: Remission Rate

    Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR)

    Measured: 3 months post CAR-T cells infusion

Secondary outcomes (2)

  1. Efficacy:duration of response (DOR)

    duration of response (DOR)

    Measured: 24 months after CAR-T infusion

  2. Efficacy: progression-free survival (PFS)

    progression-free survival (PFS) time

    Measured: 24 months after CAR-T infusion

Timeline

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

  1. First posted14 Dec 2020
  2. Study start22 Oct 2020
  3. Primary completion21 Oct 2023 (estimated)
  4. Study completion21 Oct 2025 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666168
Sponsor's protocol ID
2020102
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
14 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang W, Huang C, Liu R, Zhang H, Li W, Yin S, Wang L, Liu W, Liu L. Case report: CD19-directed CAR-T cell therapy combined with BTK inhibitor and PD-1 antibody against secondary central nervous system lymphoma. Front Immunol. 2022 Oct 5;13:983934. doi: 10.3389/fimmu.2022.983934. eCollection 2022.

    PubMed 36275715

Questions about this trial

What is this clinical trial studying?

A study testing Auto CAR-T, Cyclophosphamide,Fludarabine and Leukapheresis in people with Non-hodgkin's Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. 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 7 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 14 Dec 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.

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?

Contact Jianqiang Li, PhD & MD (008615511369555, limmune@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence and severity of adverse events (time frame: first one month after CAR-T infusion). The study lists 2 primary outcomes in all. 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 NCT04666168, which also lists 1 linked publication.

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 14 Dec 2020.

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