NCT05352828: ACTION

Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

Active, enrolled Phase 1 Last updated 3 April 2023

What this trial tests

Phase 1 trial testing Nivolumab in Classical Hodgkin Lymphoma in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 July 2022

Primary endpoint
15 December 2025

15 December 2037

Quick facts

Lead sponsor	Tessa Therapeutics
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	25 July 2022
Primary completion	15 December 2025
Estimated completion	15 December 2037
Sites	5 locations across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Autologous CD30.CAR-T — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Bendamustine (BENDAMUSTINE) — full drug profile →

Conditions studied

• Classical Hodgkin Lymphoma — all drugs for Classical Hodgkin Lymphoma →
• Hodgkin Disease Refractory — all drugs for Hodgkin Disease Refractory →
• Hodgkin Disease Recurrent — all drugs for Hodgkin Disease Recurrent →

Sponsor

Tessa Therapeutics — full company profile →

Who can join

12 and older, any sex, with Classical Hodgkin Lymphoma or Hodgkin Disease Refractory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Publications & conference data

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

1. Mechanisms of tumor resistance to immune checkpoint blockade and combination strategies to overcome resistance.
   Zhou X, Ni Y, Liang X, Lin Y, et al · · 2022 · cited 64× · PMID 36189283 · DOI 10.3389/fimmu.2022.915094
2. Combination strategies to optimize the efficacy of chimeric antigen receptor T cell therapy in haematological malignancies.
   Xiao X, Wang Y, Zou Z, Yang Y, et al · · 2022 · cited 20× · PMID 36091028 · DOI 10.3389/fimmu.2022.954235
3. Advances in Hodgkin Lymphoma Treatment: From Molecular Biology to Clinical Practice.
   Benevolo Savelli C, Bisio M, Legato L, Fasano F, et al · · 2024 · cited 14× · PMID 38791909 · DOI 10.3390/cancers16101830
4. Checkpoint inhibition in hematologic malignancies.
   Tsumura A, Levis D, Tuscano JM. · · 2023 · cited 14× · PMID 37920162 · DOI 10.3389/fonc.2023.1288172
5. Targeting natural killer cells: from basic biology to clinical application in hematologic malignancies.
   Shang J, Hu S, Wang X. · · 2024 · cited 13× · PMID 38396050 · DOI 10.1186/s40164-024-00481-y
6. Chimeric Antigen Receptor-T Cell Therapy for Lymphoma: New Settings and Future Directions.
   Benevolo Savelli C, Clerico M, Botto B, Secreto C, et al · · 2023 · cited 8× · PMID 38201473 · DOI 10.3390/cancers16010046
7. Filling the Gap: The Immune Therapeutic Armamentarium for Relapsed/Refractory Hodgkin Lymphoma.
   Hazane Leroyer E, Ziegler C, Moulin C, Campidelli A, et al · · 2022 · cited 5× · PMID 36362802 · DOI 10.3390/jcm11216574
8. Pathobiological Features and Therapeutic Opportunities Linked to TNF Family Member Expression in Classic Hodgkin Lymphoma.
   Alibrahim MN, Gloghini A, Carbone A. · · 2024 · cited 4× · PMID 39682256 · DOI 10.3390/cancers16234070