Clinical Trials

As part of the CIRM Alpha Stem Cell Clinics Network, City of Hope Alpha Stem Cell Clinic is pursuing its goal to accelerate the development and delivery of stem cell therapies to patients through high quality clinical trials.

Ongoing trials include:

A Pilot Study to Evaluate the Feasibility, Safety and Engraftment of Zinc-Finger Nucleases (ZFN) CCR5 Modified CD34+ Hematopoietic Stem/Progenitor Cells (SB-728MR-HSPC) in HIV-1 (R5) Infected Patients (COH Protocol #14017)
 
Status of enrollment: Open to accrual
 
Disease Indication:
  • HIV-1 (R5) Infection w/ suboptimal CD4 levels while on cART
     
Trial Contact:

 

Phase I Study of Cellular Immunotherapy Using Central Memory Enriched T-Cells Lentivirally Transduced to Express an IL13Rα2-Specific, Hinged-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma (COH Protocol #13384)

Status of enrollment: Open to accrual

Disease Indication:

  • Malignant Glioma

    • Refractory Brain Neoplasm

    • Recurrent Brain Neoplasm
       

Trial Contact:
Fetemah Bidmeshki
626-218-9393
[email protected]

Study details on clinicaltrials.gov

 

Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With Relapsed or Refractory CD123+ Acute Myeloid Leukemia (COH Protocol #13272)

Status of enrollment: Open to accrual

Disease Indication:

  • Relapsed Acute Myeloid Leukemia

  • Refractory Acute Myeloid Leukemia
     

Trial Contact:
Lihua Budde, M.D., Ph.D.
800-826-4673
[email protected]

Study details on clinicaltrials.gov

 

A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T cells in HLA-A2+ Patients with Synovial Sarcoma (COH Protocol #15242)

Status of enrollment: Open to accrual

Disease Indication:

  • Synovial Sarcoma
     

Trial Contact:
Warren Chow, M.D.
626-218-9200
[email protected]

Study details on clinicaltrials.gov

 

A Phase I/ II Dose Escalation Open Label Clinical Trial Evaluating the Safety and Efficacy of MAGE A10ᶜ⁷⁹⁶T in Subjects With Stage IIIb or Stage IV Non-Small Cell Lung Cancer (COH Protocol #15303)

Status of enrollment: Open to accrual

Disease Indication:

  • Advanced Non-Small Cell Lung Cancer (Stage IIIb or IV)

  • Recurrent Non-Small Cell Lung Cancer
     

Trial Contact:
Karen Reckamp, M.D.
626-218-9200
[email protected]

Study details on clinicaltrials.gov

 

A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects With Non-Small Cell Lung Cancer (COH Protocol #15346)

Status of enrollment: Open to accrual

Disease Indication:

  • Advanced Non-Small Cell Lung Cancer (Stage IIIb or IV)

  • Recurrent Non-Small Cell Lung Cancer
     

Trial Contact:
Karen Reckamp, M.D.
626-218-9200
[email protected]

Study details on clinicaltrials.gov

 

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (NHL) (COH Protocol #15209)

Status of enrollment: Open to accrual

Disease Indication:

  •  B-cell Non-Hodgkin Lymphoma (NHL)
     

Trial Contact:
Tanya Siddiqi, M.D.
626-218-2405
[email protected]

 

A Phase I, Open-Label, Ascending Dose Study to Assess the Safety and Tolerability of AAV2/6 Factor IX Gene Therapy Via Zinc Finger Nuclease (ZFN) Mediated Targeted Integration of SB-FIX in Adult Subjects With Severe Hemophilia B (COH Protocol #15420)

Status of enrollment: Open to accrual

Disease indication:
  • Hemophilia B
     
Trial Contact:
Nadia P Ewing, M.D.
626-256-4673, ext. 88858
[email protected]

 

Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas (COH Protocol #14108)

Status of enrollment: Open to accrual

Disease indication:

  • Adult Anaplastic Astrocytoma

  • Adult Anaplastic Oligoastrocytoma

  • Adult Anaplastic Oligodendroglioma

  • Adult Glioblastoma

  • Adult Gliosarcoma

  • Recurrent Adult Brain Tumor

  • Glioma
     

Trial Contact:
Jana Portnow, M.D.
626-218-9200
[email protected]

Study details at clinicaltrials.gov


A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2) (COH Protocol #15166)

Status of enrollment: Open to accrual

Disease indication:

  • Relapsed/Refractory Mantle Cell Lymphoma
     

Trial Contact:
Hormoz Mirshkarlo     
[email protected]

Study details on clinicaltrials.gov


A Study Evaluating KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (ZUMA-6) (COH Protocol #16279)

Status of enrollment: Open to accrual

Disease indication:

  • Refractory Diffuse Large B Cell Lymphoma
     

Trial Contact:
Hormoz Mirshkarlo     
[email protected]

Study details on clinicaltrials.gov

 

Multicentre, Randomized, Open-Label, Phase III Clinical Trial for Advanced Nasopharyngeal Carcinoma Patients (COH Protocol #16367)

Status of enrollment: Open to accrual

Disease indication:

  • Nasopharyngeal Cancer
     

Trial Contact:
Erminia Massarelli M.D, Ph.D.
626-218-9200

Study details at clinicaltrials.gov

 

NY-ESO-1C259T Alone and in Combination With Pembrolizumab for Multiple Myeloma (COH Protocol #17171)

Status of enrollment: Open to accrual

Disease indication:

  • HLA-A2+ SUBJECTS WITH NY-ESO-1 AND/OR LAGE-1A POSITIVE

  • RELAPSED AND REFRACT ORY MULTIPLE MYELOMA
     

Trial Contact:
Hormoz Babaei Mirshkarlo
626-218-8074
[email protected]

Study details at clinicaltrials.gov

 

Dose-Ranging Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 in Subjects with Severe Hemophilia A (COH Protocol #17068)

Status of enrollment: Open to accrual

Disease indication:

  • Hemophilia A
     

Trial Contact:  
Janice Kim, CCRP    
626-218-4350    
[email protected]  

Study details at clinicaltrials.gov

 

An Exploratory Phase 1/2 Trial To Evaluate the Safety and Efficacy of JCAR017 Combinations in Subjects with Relapsed/Refractory B-Cell Malignancies (PLATFORM) (COH Protocol #17198)

Status of enrollment: Open to accrual
 
Disease indication:
  • Non-Hodgkin Lymphoma,
  • Large B-Cell, Diffuse Lymphoma,
  • Follicular Lymphoma
     
 
 
An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (COH Protocol #17273)

Status of enrollment: Open to accrual

Disease indication:
  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Relapsed or Refractory Small Lymphocytic Lymphoma
     
Trial Contact:
Hormoz Mirshkarlo
[email protected]

Study details at clinicaltrials.gov
 
 

An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed or Refractory Multiple Myeloma (COH Protocol #17405)

Status of enrollment: Open to accrual

Disease indication:

  • Relapsed or Refractory Multiple Myeloma
     

Trial Contact:
Myo Htut, MD    
Phone: 626-218-2405
[email protected]  

Study details at clinicaltrials.gov
 

A Pilot Study to Evaluate the Safety and Feasibility of Induction of Mixed Chimerism in Sickle Cell Disease Patients with COH-MC-17: A Non-Myeloablative Conditioning Regimen and CD4+ T Cell-Depleted Haploidentical Hematopoietic Transplant (COH Protocol #16453)

Status of enrollment: Open to accrual

Disease indication:

  • Sickle Cell Disease
     

Trial Contact:
Joseph Rosenthal, MD   
626-256-4673
[email protected]  

Study details at clinicaltrials.gov
 

Acquisition of Skin Biopsy Samples from Healthy Volunteers and Patients Diagnosed with X-Linked Adrenoleukodystrophy (ALD), Canavan Disease (CD) and other Inherited Leukodystrophies (COH Protocol #16321)

Status of enrollment: Open to accrual

Disease indication:

  • Healthy volunteers
  • X-Linked Adrenoleukodystrophy (ALD)
  • Canavan Disease (CD)
  • Other Inherited Leukodystrophies
     

Trial Contact:
Yanhong Shi, PhD
626-218-4485
[email protected]