Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03468153

Enrollment

Registered

2018-03-16

Start date

2018-01-01

Completion date

2020-01-01

Last updated

2018-03-20

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

Conditions

Lymphoma

Brief summary

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Interventions

BIOLOGICALDual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

Patient-derived dual specificity CD19 and CD22 CAR-T Cells

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

* Histological detection confirmed CD19/CD22 postive lymphoma; * Recieved more than 2 lines of chemotherapy; * Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation; * Life expectation for more than 3 months; * ECOG ≥ 2; * Adequate 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

* Immunosuppressive agents or steroids in recent 1 week before recruitment; * Uncontrolled infection; * HIV positive ; * 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.

Design outcomes

Primary

Measure	Time frame	Description
Overall remission rate	4 weeks after infusion	Rate of complete remission and patial remission

Secondary

Measure	Time frame	Description
Adverse toxicity	Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused	According to CTCAE 4.0 criteria

Countries

China

Contacts

Primary ContactWeili Zhao, MD

zhao.weili@yahoo.com64370045

Outcome results

None listed

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