NCT03910842

Treatment of Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy

Status unknown EARLY_PHASE1 Last updated 6 September 2019

What this trial tests

EARLY_PHASE1 trial testing CD19-TriCAR-T/SILK in Non-Hodgkin Lymphoma of Intestine in 12 participants. Status unknown.

Timeline

21 March 2019

Primary endpoint
15 April 2022

15 October 2022

Quick facts

Lead sponsor	Timmune Biotech Inc.
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	21 March 2019
Primary completion	15 April 2022
Estimated completion	15 October 2022
Sites	1 location across China

Drugs / interventions tested

• CD19-TriCAR-T/SILK — full drug profile →

Conditions studied

• Non-Hodgkin Lymphoma of Intestine — all drugs for Non-Hodgkin Lymphoma of Intestine →
• Leukemia — all drugs for Leukemia →

Sponsor

Timmune Biotech Inc. — full company profile →

Who can join

Under 18, any sex, with Non-Hodgkin Lymphoma of Intestine or Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selection of new immunotherapy targets for NK/T cell lymphoma.
   Lv K, Li X, Yu H, Chen X, et al · · 2020 · cited 17× · PMID 33312349
2. The future of cellular immunotherapy for childhood leukemia.
   Bonifant CL, Tasian SK. · · 2020 · cited 15× · PMID 31851053 · DOI 10.1097/mop.0000000000000866
3. Advances and challenges of immunotherapies in NK/T cell lymphomas.
   He L, Chen N, Dai L, Peng X. · · 2023 · cited 12× · PMID 38026157 · DOI 10.1016/j.isci.2023.108192
4. CAR-NK cells: harnessing the power of natural killers for advanced cancer therapy.
   Dos Reis FD, Saidani Y, Martín-Rubio P, Sanz-Pamplona R, et al · · 2025 · cited 11× · PMID 40519903 · DOI 10.3389/fimmu.2025.1603757
5. A Review of Chimeric Antigen Receptor T-Cell Therapy for Myeloma and Lymphoma.
   Atrash S, Moyo TK. · · 2021 · cited 11× · PMID 33814917 · DOI 10.2147/ott.s242018
6. Clinical development of chimeric antigen receptor-T cell therapy for hematological malignancies.
   Yang Z, Wang Y. · · 2023 · cited 9× · PMID 37358555 · DOI 10.1097/cm9.0000000000002549
7. Chimeric antigen receptor natural killer cells: a promising antitumor immunotherapy.
   Wang Y, Jin S, Zhuang Q, Liu N, et al · · 2023 · cited 8× · PMID 38045827 · DOI 10.1002/mco2.422
8. Clinical development of natural killer cells expressing chimeric antigen receptors.
   Golden RJ, Fesnak AD. · · 2021 · cited 2× · PMID 33468407 · DOI 10.1016/j.transci.2021.103065