Trials / Recruiting
RecruitingNCT05798897
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 79 (estimated)
- Sponsor
- Marker Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\^6 cells (flat dosing).
Detailed description
This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who either relapsed or had incomplete response after cluster of differentiation (CD) 19-directed chimeric antigen receptor (CAR) T cell therapy or are CAR T cell therapy naïve (ineligible or refused CD19-directed CAR T cell therapy or for whom CAR T cell therapy is not available). The study will consist of two portions or phases: 1) Dose Escalation with allowance for backfilling cohorts (up to 50 participants) followed by 2) Dose Expansion at the preliminary RP2DS in 1-2 disease specific cohorts of up to 29 participants each. The Dose Expansion portion of this study will begin after completion of the Dose Escalation portion. The purpose of the Dose Expansion portion of the study is to evaluate the clinical efficacy of MT-601 at the dose determined to be safe in the Dose Escalation portion.
Conditions
- Non-Hodgkin Lymphoma, Adult
- Non-Hodgkin Lymphoma, Refractory
- Non-Hodgkin Lymphoma, Relapsed
- Non Hodgkin Lymphoma
- Hodgkin Lymphoma
- Hodgkin Lymphoma, Adult
- Hodgkin's Lymphoma, Relapsed, Adult
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MT-601 | Multi-antigen specific CD4+ andCD8+ T cells |
Timeline
- Start date
- 2023-01-02
- Primary completion
- 2028-02-28
- Completion
- 2028-02-28
- First posted
- 2023-04-05
- Last updated
- 2025-08-20
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05798897. Inclusion in this directory is not an endorsement.