Chronic Lymphocytic Leukemia Clinical Trial

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

Summary

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and leukemia-cll/" >CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

For subjects with LBCL:

Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
At least 1 measurable lesion at time of enrollment
Relapsed or refractory disease after at least 2 lines of chemotherapy
Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)

For subjects with CLL/SLL:

Diagnosis of CLL/SLL
Relapsed/refractory disease
Subjects relapsed/refractory to BTKi therapy and high-risk disease
Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax)
At least 1 measurable lesion at time of enrollment

For all subjects:

Male or female subjects ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Adequate hematological, renal, and liver function

Exclusion Criteria:

Active central nervous system (CNS) involvement by malignancy
Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
Any other active malignancies that required systemic treatment within 3 years prior to enrollment
Radiation therapy within 2 weeks prior to ALLO-647
Prior irradiation to >25% of the bone marrow
Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).
Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT04416984

Recruitment Status:

Recruiting

Sponsor:

Allogene Therapeutics

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There are 38 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Yasmin Adam
Contact
480-256-3985
[email protected]
Mayo Clinic Hospital
Phoenix Arizona, 85054, United States More Info
Tiffany Tran
Contact
480-301-8000
[email protected]
City of Hope
Duarte California, 91010, United States More Info
Geoffrey Shouse, MD
Contact
[email protected]
UCLA Medical Center
Los Angeles California, 90095, United States More Info
Christopher Hannigan
Contact
310-794-6500
[email protected]
Stanford Cancer Institute
Palo Alto California, 94035, United States More Info
Linnea Nichols
Contact
650-724-9050
[email protected]
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Ben Burtness
Contact
303-981-2305
[email protected]
Yale School of Medicine
New Haven Connecticut, 06510, United States
University of Miami
Miami Florida, 33136, United States
Advent Health
Orlando Florida, 06510, United States More Info
Rushang Patel, MD
Contact
[email protected]
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Rebecca Delph
Contact
[email protected]
Northside Hospital - Atlanta
Atlanta Georgia, 30342, United States More Info
Caitlin Guzowski
Contact
404-851-8523
[email protected]
Augusta University
Augusta Georgia, 30912, United States More Info
Kelly Jenkins
Contact
706-721-1206
[email protected]
Loyola University Medical Center
Maywood Illinois, 60153, United States More Info
Rachel Martino
Contact
708-327-3317
[email protected]
Norton Cancer Institute
Louisville Kentucky, 40207, United States More Info
Ashley Spalding
Contact
[email protected]
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Grace Bae
Contact
313-576-8030
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Avera Medical
Sioux Falls South Dakota, 57117, United States
Vanderbilt Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Olalekan Oluwole, MD
Contact
615-936-8422
[email protected]
St. David's South Austin Medical Center
Austin Texas, 78704, United States More Info
Tiffany Cardona
Contact
615-329-7236
[email protected]
Texas Oncology
Dallas Texas, 75251, United States More Info
Christine Terraciano
Contact
214-370-1942
[email protected]
MD Anderson Cancer Center - University of Texas
Houston Texas, 77030, United States More Info
Swapna Binoy
Contact
713-792-8251
[email protected]
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
St. Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
QEII Health Sciences Centre-VG Site
Halifax Nova Scotia, B3H 2, Canada
CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus
Québec , G1J 1, Canada
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna , 40138, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan , 20132, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Hospital Universitari Vall d'Hebrón
Barcelona , 08035, Spain
Hospital Universitario Donostia
Donostia-San Sebastian , 20014, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Complot Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT04416984

Recruitment Status:

Recruiting

Sponsor:


Allogene Therapeutics

How clear is this clinincal trial information?

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