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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with advanced gastrointestinal (GI) cancers.
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DISP-10 | Experimental | Participants will receive DV-10 in combination with ide-cel. Lymphodepleting chemotherapy (fludarabine and cyclophosphamide) will be administered a few days prior to ide-cel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DISP-10 | Biological | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce ide-cel. During ide-cel production, participants may receive bridging therapy for disease control per Investigator discretion. DV-10 administration will be followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide) and subsequent ide-cel administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0 | 90 days (2 years for related Serious Adverse Events) |
| Incidence of Dose Limiting Toxicities (DLTs) [PART 1] | Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0 | 28 days |
| Identification of the Recommended Dose for Expansion (RDE) [PART 1] | To select the Recommended Dose for Expansion (RDE) for Part 2 | Up to 2 years |
| Overall response rate (ORR) [PART 2] | Confirmed complete response (CR) or partial response (PR), per RECIST v1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) [PART 1] | Confirmed CR or PR, per RECIST v1.1 | Up to 2 years |
| Disease control rate (DCR) | Proportion of participants with CR, PR, or stable disease per RECIST v1.1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dispatch Clinical | Contact | (215) 792-4699 | clinicaltrials@dispatchbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| University of Cincinnati Cancer Center |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000257 | Adenoviridae Infections |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Up to 2 years |
| Duration of response (DOR) | Time from CR or PR to radiographic progression or death | Up to 2 years |
| Progression Free Survival (PFS) | Time from ide-cel administration to disease progression or death, whichever occurs first | Up to 2 years |
| Overall survival (OS) | Time from ide-cel administration to death | Up to 15 years |
| Time to response (TTR) | Time from ide-cel administration to the first documentation of objective tumor response | Up to 2 years |
| Cellular kinetics (CK) of ide-cel | Measurement of ide-cel CK in the blood | Up to 2 years |
| Pharmacokinetics of DV-10 - Cmax | Maximum concentration in blood | Up to 2 years |
| Pharmacokinetics of DV-10 - Tmax | Time to maximum concentration in blood | Up to 2 years |
| Pharmacokinetics of DV-10 - AUC | Area under the blood concentration curve | Up to 2 years |
| Recruiting |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |