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Status unknownNCT05349266Updated Apr 27, 2022

Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

A Phase 1 interventional study of ThisCART19A in Non-Hodgkin's Lymphoma, sponsored by Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.

02

Conditions studied

  • Non-Hodgkin's Lymphoma
03

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 16 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.
  • Failing to autologous CAR-T therapy.
  • At least one available lesion to be assessed.
  • Good organ function during screening.
  • Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.

Exclusion criteria

Exclusion Criteria:

  • Allergic to preconditioning measures.
  • Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
  • Uncontrollable bacterial, fungal and viral infection during screening.
  • Patients had pulmonary embolism within 3 months prior to enrollment.
  • Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
  • Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment.
  • Had big lesion(single lesion diameter ≥10 cm).
  • Bone marrow involvement≥5%.
  • Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
  • Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
  • Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
  • Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
  • Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    ThisCART19A 2×10^6 cells/kg for dose level 1

    Patients will receive 2×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

  • Experimental
    ThisCART19A 3×10^6 cells/kg as dose level 2

    Patients will receive 3×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

  • Experimental
    Patients will receive 4×10^6 cells/kg as dose level 3

    Patients will receive 4×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

Interventions

  • BiologicalThisCART19A

    each patient will receive a dose level per body weight(kg) for only once.

06

What researchers measure

Primary outcomes

  1. Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage

    DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

    Time frame: 28 days

  2. Objective Response Rate in patient with NHL during dose expansion stage

    the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment

    Time frame: 12 months

Secondary outcomes

  1. Objective Response Rate during dose escalation stage and expansion stage

    the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment

    Time frame: 12 months

  2. Duration of response(DOR) during dose escalation stage and expansion stage

    The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR)

    Time frame: 12 months

  3. OS(overall survival) during dose escalation stage and expansion stage

    Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.

    Time frame: 12 months

  4. Time to remission(TTR) during dose escalation stage and expansion stage

    Time to remission(TTR) is defined as the time from the date of ThisCART19A infusion until the date of first remission.

    Time frame: 12 months

  5. Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages

    Track CAR T cells expansion in patients after infusion

    Time frame: 6 months

  6. Analysis the change characteristics of cytokines and immune effect cells number during dose escalation and expansion stages

    Analysis the effect cells and cytokines in patient after infusion

    Time frame: 3 months

  7. Analysis the severity and Incidence of Adverse Events in each dose level during dose expansion stage

    Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention

    Time frame: 3 months

  8. Analysis the immunogenicity(anti-therapeutic antibody and neutralizing antibody) of CAR-T cells after infusion

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • The first affiliated hospital of medical college of zhejiang university
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05349266
Lead sponsor
Zhejiang University
Responsible party
He Huang (President/Proffessor, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Apr 27, 2022
Start date
Mar 18, 2022
Primary completion
Mar 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Apr 27, 2022

Study contacts

Ming Ming Zhang, Doctor
Contact
mingmingzhang@zju.edu.cn
13656674208
He Huang, Doctor
principal investigator · First hospital affiliated Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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