Clinical trial · Interventional
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Percutaneously-Accessible Solid Tumors and Mycosis Fungoides
- 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)
This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus-Related Malignant Neoplasm | Human Papillomavirus-Related Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Merkel-cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTI-621 Monotherapy | Drug | — | UNRESOLVED |
| TTI-621 + PD-1/PD-L1 Inhibitor | Drug | — | UNRESOLVED |
| TTI-621 + pegylated interferon-α2a | Drug | — | UNRESOLVED |
| TTI-621 + radiation | Other | — | UNRESOLVED |
| TTI-621 + T-Vec | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- TTI-621 Monotherapy Escalation
- description
- TTI-621 Escalation phase of single or multiple doses of TTI-621 delivered by intratumoral injections (various dose cohorts).
- interventionNames
- Drug: TTI-621 Monotherapy
- type
- EXPERIMENTAL
- label
- TTI-621 Monotherapy (Single Lesion)
- description
- TTI-621 Single Lesion Injection Expansion Cohort
- interventionNames
- Drug: TTI-621 Monotherapy
- type
- EXPERIMENTAL
- label
- TTI-621 Monotherapy (Multiple Lesions)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides) * Adequate renal function * Adequate coagulation function * Adequate hepatic function * Disease that has progressed on standard therapy or for whom there is no other therapy option available Exclusion Criteria: * Central nervous system involvement * Significant cardiovascular disease * Active autoimmune disease * Active hepatitis B or C or a history of HIV infection * Uncontrolled infection * History of hemolytic anemia or bleeding diathesis
References
Publications (2)
- DERIVEDQuerfeld C, Thompson JA, Taylor MH, DeSimone JA, Zain JM, Shustov AR, Johns C, McCann S, Lin GHY, Petrova PS, Uger RA, Molloy N, Shou Y, Akilov OE. Intralesional TTI-621, a novel biologic targeting the innate immune checkpoint CD47, in patients with relapsed or refractory mycosis fungoides or Sezary syndrome: a multicentre, phase 1 study. Lancet Haematol. 2021 Nov;8(11):e808-e817. doi: 10.1016/S2352-3026(21)00271-4. Epub 2021 Oct 7. PMID 34627593
- DERIVEDKruglov O, Johnson LDS, Minic A, Jordan K, Uger RA, Wong M, Sievers EL, Shou Y, Akilov OE. The pivotal role of cytotoxic NK cells in mediating the therapeutic effect of anti-CD47 therapy in mycosis fungoides. Cancer Immunol Immunother. 2022 Apr;71(4):919-932. doi: 10.1007/s00262-021-03051-x. Epub 2021 Sep 14. PMID 34519839