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NCT Number: NCT03196830

CAR-T for R/R B-NHL

This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.

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Key information

Conditions

Relapsed Non Hodgkin Lymphoma CAR - T CD19/CD20/CD22/CD30 Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Refractory Non-Hodgkin Lymphoma

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma
  • Recieved more than 2 lines of chemotherapy
  • With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation
  • Expected survival more than 3 months
  • Karmofsky performance score ≤ 60, and ECOG ≥ 2.
  • Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%
  • CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L
  • Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
  • With measurable disease
  • Written informed consent could be acquired

Exclusion criteria

  • Received immunol suppression treatment or steroids in recent 1 week before recruitment
  • Uncontrolled infection
  • HIV positive patients
  • Active HBV or HCV infection
  • Women in pregnancy and lactation
  • Refuse to conception control during treatment and 1 year after CAR-T infusion
  • Uncured malignancies other than non-Hodgkin lymphoma
  • Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma
  • Inheritated immune deficiancy
  • Severe heart disease

Treatment and study plan

CAR-T

Biological

For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy

Primary outcomes

  1. Overall Response Rate

    Time frame: One months after CAR-T cells were infused

    Rate of complete remission and patial remission

Secondary outcomes

  1. Adverse toxicity

    Time frame: Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused

    Accordingto CTCAE 4.0 criteria

  2. CAR-T cell survival

    Time frame: every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years

    the survival of CAR-T cells detected in patients' peripheral blood

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Registry information

Official study title

Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2017
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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