Trial · NCT04614636
FT538 in Subjects With Advanced Hematologic Malignancies
NCT04614636, Phase 1, Terminated, Fate Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FT538 in Subjects With Advanced Hematologic Malignancies. Trials, record NCT04614636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04614636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FT538 in Subjects With Advanced Hematologic Malignancies
- NCT number
- NCT04614636
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- Fate Therapeutics
- Conditions
- Acute Myeloid Leukemia, AML, Adult, Multiple Myeloma, Myeloma
- Interventions
- FT538, Cyclophosphamide, Fludarabine, Daratumumab, Elotuzumab
- First posted
- 2020-11-04
- Last updated
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) within each dose level cohort | Cycle 1, Up to Day 29 | |
| Primary | Nature of dose-limiting toxicities within each dose level cohort | Cycle 1, Up to Day 29 | |
| Secondary | Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma | Up to 5 years | |
| Secondary | Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | From baseline tumor assessment up to approximately 2 years after last dose of FT538 | Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria |
| Secondary | Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria |
| Secondary | Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria |
| Secondary | Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM |
| Secondary | Event-free survival (EFS) of FT538 as monotherapy in r/r AML | Up to 15 years | defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria |
| Secondary | Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | defined as the time from first dose of lympho-conditioning to death from any cause |
| Secondary | Time-to-best response of FT538 as monotherapy in r/r AML | Up to 15 years | defined as the time from first dose of lympho-conditioning to best response |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04614636
GET https://conductscience.org/api/trials/v1/NCT04614636/registered