---
title: Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
nct_id: NCT03790891
overall_status: UNKNOWN
phase: EARLY_PHASE1
sponsor: Timmune Biotech Inc.
study_type: INTERVENTIONAL
primary_condition: Non-Hodgkin Lymphoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03790891.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03790891"
ct_last_update_post_date: 2020-03-13
last_seen_at: "2026-05-12T06:04:31.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy

**Official Title:** Adoptive Immunotherapy for Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell

**NCT ID:** [NCT03790891](https://clinicaltrials.gov/study/NCT03790891)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Timmune Biotech Inc.
- **Conditions:** Non-Hodgkin Lymphoma
- **Start Date:** 2019-01-05
- **Completion Date:** 2022-01-01
- **CT.gov Last Update:** 2020-03-13

## Brief Summary

This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.

## Detailed Description

CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma，blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri-functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR-NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
2. All subjects must be able to comply with all the scheduled procedures in the study;
3. Refractory or relapsed malignant Non-Hodgkin lymphoma, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed in ≤12 months of ASCT;
4. At least one measurable lesion per revised IWG Response Criteria;
5. Aged \<70 years;
6. Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2;
7. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
8. All other treatment induced adverse events must have been resolved to ≤grade 1;
9. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB\>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

1. Presence of fungal, bacterial, viral, or other infection that is hardly to control（defined by investigator）;
2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
3. Lactating women or women of childbearing age who plan to conceive during the time period;
4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
5. Known history of infection with HIV;
6. Subjects need systematic usage of corticosteroid;
7. Subjects need systematic usage of immunosuppressive drug;
8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
9. Other reasons the investigator consider the patient may not be suitable for the study.
```

## Arms

- **CD19-TriCAR-T/SILK** (EXPERIMENTAL) — CD19-TriCAR-T/SILK cells will be administered intravenously

## Interventions

- **CD19-TriCAR-T/SILK** (BIOLOGICAL) — A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.

## Primary Outcomes

- **safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03）** _(time frame: 24 months)_ — Incidence of treatment-related adverse events as assessed by CTCAE v4.03

## Secondary Outcomes

- **Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)** _(time frame: 24 months)_
- **Partial response rate [PR] （Partial response rate per the revised International Working Group (IWG) Response Criteria）** _(time frame: 24 months)_
- **Duration of Response （The time from response to relapse or progression）** _(time frame: 24 months)_
- **Progression Free Survival （The time from the first day of treatment to the date on which disease progresses）** _(time frame: 24 months)_
- **Overall Survival （The number of patient alive, with or without signs of cancer）** _(time frame: 24 months)_

## Locations (3)

- Hainan Cancer Hospital, Haikou, Hainan, China — _RECRUITING_
- Hainan General Hospital, Haikou, Hainan, China — _RECRUITING_
- The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hainan cancer hospital|haikou|hainan|china` — added _(2026-05-12)_
- `locations.hainan general hospital|haikou|hainan|china` — added _(2026-05-12)_
- `locations.the second affiliated hospital of hainan medical university|haikou|hainan|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03790891*  
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