Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02965157

Enrollment

Registered

2016-11-16

Start date

2016-08-31

Completion date

Unknown

Last updated

2016-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, B-Cell

Brief summary

Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Interventions

BIOLOGICALCART20

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Relapsed or refractory CD20+ B-cell lymphoma. 2. Measurable disease. 3. Performance status ECOG 0-2. 4. Age:18-65. 5. Fertile females/males must consent to use contraceptives during participation of the trial. 6. Signed informed consent

Exclusion criteria

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. Patients with primary CNS lymphoma. 3. Known human immunodeficiency virus (HIV) infection. 4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). 5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. 6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. 7. Patients that do not consent to that tissue and blood samples are stored in a biobank. 8. Pregnancy. \-

Design outcomes

Primary

Measure	Time frame
all cause mortality	one year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026