Clinical Trials

Multiple clinical trials, ranging from Phase 1 safety evaluations to Phase 3 investigations, evaluate rimiducid (AP1903) as an inducible dimerizer switch for cell therapy control across active, non-recruiting, and planned stages. Sponsored by industry and academic entities such as Bellicum Pharmaceuticals, Poseida Therapeutics, and M.D. Anderson Cancer Center, these studies target graft-versus-host disease, pediatric brain tumors like diffuse intrinsic pontine glioma, and hematologic malignancies including acute myeloid leukemia, multiple myeloma, and lymphoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06066424 RECRUITING
Solid Tumors
M.D. Anderson Cancer Center
2023-10-24 PHASE1
NCT07553390 NOT_YET_RECRUITING
Breast Cancer
M.D. Anderson Cancer Center
2026-10-01 PHASE1
NCT06984341 WITHDRAWN
Systemic Lupus Erythematosus
Genentech, Inc.
2026-06-30 PHASE1
NCT03741127 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Poseida Therapeutics, Inc.
2018-10-29 PHASE1
NCT07164469 NOT_YET_RECRUITING
Large B-cell Lymphoma; Hodgkin Lymphoma
M.D. Anderson Cancer Center
2026-12-28 PHASE2
NCT01494103 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelogenous Leukemia; Non Hodgkin Lymphoma; Hemophagocytic Lymphohistiocytosis; Familial Hemophagocytic Lymphohistiocytosis; Hemophagocytic Syndrome; Epstein Barr Virus Infection; X-linked Lymphoproliferative Disease
Baylor College of Medicine
2011-11 PHASE1
NCT06014762 ACTIVE_NOT_RECRUITING
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; High-grade B-cell Lymphoma; Primary Mediastinal Large B-cell Lymphoma (PMBCL); Transformed Follicular Lymphoma (tFL); Follicular Lymphoma Grade 3B; DLBCL; DLBCL - Diffuse Large B Cell Lymphoma; DLBCL Arising From Follicular Lymphoma; DLBCL, Diffused Large B Cell Lymphoma; DLBCL NOS
Poseida Therapeutics, Inc.
2024-04-16 PHASE1
NCT04960579 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Poseida Therapeutics, Inc.
2022-05-05 PHASE1
NCT06358430 ACTIVE_NOT_RECRUITING
Colorectal Cancer; Minimal Residual Disease
M.D. Anderson Cancer Center
2024-12-02 PHASE1
NCT07509008 NOT_YET_RECRUITING
Gastric Cancer, Metastatic
M.D. Anderson Cancer Center
2026-09-01 PHASE1; PHASE2
NCT07598955 RECRUITING
B2 Thymoma; Thymic Carcinoma
Beijing Biotech
2026-03-02 PHASE1; PHASE2
NCT02792114 ACTIVE_NOT_RECRUITING
Breast Cancer; Metastatic HER2-negative Breast
Memorial Sloan Kettering Cancer Center
2016-06 PHASE1
NCT05239143 ACTIVE_NOT_RECRUITING
Breast Cancer; Ovarian Cancer; Non Small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer; Renal Cell Carcinoma; Nasopharyngeal Cancer; Head and Neck Squamous Cell Carcinoma; Gastric Cancer
Poseida Therapeutics, Inc.
2022-02-15 PHASE1
NCT03016377 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; Immune System Diseases; Immunoproliferative Disorders
UNC Lineberger Comprehensive Cancer Center
2012-03-22 PHASE1
NCT03696784 ACTIVE_NOT_RECRUITING
Lymphoma; Lymphoma, B-Cell; Immune System Diseases; Immunoproliferative Disorders; Lymphatic Diseases
UNC Lineberger Comprehensive Cancer Center
2019-03-12 PHASE1
NCT04249947 TERMINATED
Prostatic Neoplasms, Castration-Resistant; Neoplasms by Histologic Type; Neoplasms, Prostate; Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Neoplasms; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Prostatic Disease; Salivary Gland Cancer; Salivary Gland Tumor; Adenoid Cystic Carcinoma; Salivary Duct Carcinoma; Mucoepidermoid Carcinoma; Acinic Cell Tumor
Poseida Therapeutics, Inc.
2020-02-28 PHASE1
NCT05298995 Recruiting
Brain Tumor Pediatric|Medulloblastoma Childhood|Embryonal Tumor|High Grade Glioma|Diffuse Midline Glioma|Diffuse Intrinsic Pontine Glioma|Brain Tumor Adult
Bambino Gesù Hospital and Research Institute
2023-11-09 Phase 1
NCT02744287 TERMINATED
Metastatic Castration-resistant Prostate Cancer; Metastatic Prostate Cancer
Regeneron Pharmaceuticals
2016-11-30 PHASE1
NCT03056339 COMPLETED
B-Lymphoid Malignancies; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Non-hodgkin Lymphoma
M.D. Anderson Cancer Center
2017-06-21 PHASE1; PHASE2
NCT03459170 ACTIVE_NOT_RECRUITING
Hematologic Malignancy
Bellicum Pharmaceuticals
2018-02-01 PHASE1
NCT03288493 TERMINATED
Multiple Myeloma
Poseida Therapeutics, Inc.
2017-09-20 PHASE1; PHASE2
NCT02849886 TERMINATED
Graft Versus Host Disease; Hematological Malignancies
Centre Hospitalier Universitaire de Besancon
2019-04-10 PHASE1; PHASE2
NCT03301168 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; Leukemia, Acute Myeloid (AML), Child; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Primary Immune Deficiency Disorder; Osteopetrosis; Cytopenia; Hemoglobinopathy in Children; Anemia, Aplastic
Bellicum Pharmaceuticals
2014-04 PHASE1; PHASE2
NCT03807063 WITHDRAWN
Acute Bilineal Leukemia; Myelodysplastic/Myeloproliferative Neoplasm; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Myeloproliferative Neoplasm; Recurrent Acute Biphenotypic Leukemia; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome
Fred Hutchinson Cancer Center
2020-01-02 PHASE1
NCT03958656 COMPLETED
Myeloma-Multiple; Myeloma, Plasma-Cell
National Cancer Institute (NCI)
2019-06-13 PHASE1
NCT03733249 TERMINATED
Acute Lymphoblastic Leukemia; Leukemia, Acute Myeloid (AML), Child; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Primary Immunodeficiency; Anemia, Aplastic; Hemoglobinopathies; Cytopenia; Fanconi Anemia; Diamond Blackfan Anemia; Thalassemia; Anemia, Sickle Cell
Bellicum Pharmaceuticals
2017-01 PHASE1; PHASE2
NCT02065869 TERMINATED
Acute Lymphoblastic Leukemia; Leukemia, Acute Myeloid (AML), Child; Lymphoma, Non-Hodgkin; Myelodysplastic Syndrome; Primary Immunodeficiency; Anemia, Aplastic; Osteopetrosis; Hemoglobinopathies; Cytopenia; Fanconi Anemia; Diamond Blackfan Anemia; Thalassemia; Anemia, Sickle Cell
Bellicum Pharmaceuticals
2014-04 PHASE1; PHASE2
NCT02477878 ACTIVE_NOT_RECRUITING
Leukemia; Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Hematologic Neoplasms
Bellicum Pharmaceuticals
2016-07 PHASE1
NCT03807063 Withdrawn
Acute Bilineal Leukemia|Myelodysplastic/Myeloproliferative Neoplasm|Myelodysplastic/Myeloproliferative Neoplasm Unclassifiable|Myeloproliferative Neoplasm|Recurrent Acute Biphenotypic Leukemia|Recurrent Acute Lymphoblastic Leukemia|Recurrent Acute Myeloid Leukemia|Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm|Recurrent Chronic Lymphocytic Leukemia|Recurrent Chronic Myelogenous Leukemia BCR-ABL1 Positive|Recurrent Chronic Myelomonocytic Leukemia|Recurrent Myelodysplastic Syndrome
Fred Hutchinson Cancer Center|National Cancer Institute (NCI)|Bellicum Pharmaceuticals
2020-01-02 Phase 1
NCT01744223 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Lymphoma; Myelodysplastic Syndromes
Bellicum Pharmaceuticals
2013-03 PHASE1; PHASE2
NCT03699475 TERMINATED
Acute Myeloid Leukemia; Myelodysplastic Syndromes
Bellicum Pharmaceuticals
2018-12-27 PHASE2; PHASE3
NCT02743611 TERMINATED
Acute Myeloid Leukemia; Myelodysplastic Syndrome; Uveal Melanoma
Bellicum Pharmaceuticals
2017-04-14 PHASE1; PHASE2
NCT02849886 Unknown status
Graft Versus Host Disease|Hematological Malignancies
Centre Hospitalier Universitaire de Besancon|Etablissement Français du Sang|Bellicum Pharmaceuticals
2019-04-10 Phase 1|Phase 2
NCT02786485 WITHDRAWN
Leukemia; Myelodysplastic Syndromes; Lymphomas; Multiple Myeloma; Other High-risk Hematological Malignancies
Bellicum Pharmaceuticals
2016-05 PHASE1
NCT03741127 Active not recruiting
Multiple Myeloma
Poseida Therapeutics Inc.|California Institute for Regenerative Medicine (CIRM)
2018-10-29 Phase 1
NCT02487459 WITHDRAWN
Hematologic Malignancies
Bellicum Pharmaceuticals
2016-07 PHASE1
NCT01875237 TERMINATED
Leukemia; Myeloma; Myeloproliferative Diseases
M.D. Anderson Cancer Center
2013-12-27 PHASE1; PHASE2
NCT02107963 COMPLETED
Sarcoma; Osteosarcoma; Neuroblastoma; Melanoma
National Cancer Institute (NCI)
2014-02-28 PHASE1
NCT02477878 Active not recruiting
Leukemia|Myelodysplastic Syndromes|Lymphoma|Multiple Myeloma|Hematologic Neoplasms
Bellicum Pharmaceuticals
2016-07 Phase 1
NCT01823978 COMPLETED
Castrate Resistent Prostate Cancer
Bellicum Pharmaceuticals
2013-04 PHASE1
NCT02231710 TERMINATED
Primary Immune Deficiency Disorders; Hemophagocytic Lymphohistiocytosis; Inherited Bone Marrow Failure Syndrome; Hemoglobinopathies; Metabolic Disorders
Bellicum Pharmaceuticals
2015-02 PHASE1
NCT00868595 COMPLETED
Castrate Resistant Prostate Cancer (CRPC)
Bellicum Pharmaceuticals
2009-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-15)

Check the Rimiducid (AP1903) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rimiducid acts as a synthetic small-molecule dimerizer that selectively binds engineered FKBP fusion proteins with high affinity, driving localized protein dimerization and activation of downstream intracellular signaling cascades like Fas- or caspase-mediated apoptosis. This targeted cell elimination provides an inducible safety switch mechanism that is clinically applied to mitigate toxicities and manage graft-versus-host disease or tumor growth in adoptive cell therapy trials for hematologic and pediatric malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.