Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cell therapy
- description
- Patient-derived dual specificity CD19 and CD22 CAR-T
- interventionNames
- Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Primary outcomes (1)
- measure
- Overall remission rate
- timeFrame
- 4 weeks after infusion
- description
- Rate of complete remission and patial remission
Secondary outcomes (1)
- measure
- Adverse toxicity
- timeFrame
- Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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