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Lymphoma Antigen Density and Circulating Tumor DNA Profiling As Determinants of Novel CAR Therapies

Award Number: K08CA248968
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 03/09/2020
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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Lymphoma Antigen Density and Circulating Tumor DNA Profiling As Determinants of Novel CAR Therapies - More than 80% of patients with refractory diffuse large B-cell lymphoma (DLBCL) respond to CD19- targeting chimeric antigen receptor (CAR) T cell therapy. Yet, 50% of these patients will relapse. CD19 antigen loss is a common mechanism for CD19-CAR therapy failure in B-cell acute lymphoblastic leukemia (B- ALL), and similar data is now emerging for DLBCL patients. CD22 is a B-cell malignancy associated antigen and a small Phase I trial of CD22-CAR therapy has shown promise in B-ALL even in those patients who failed CD19-CAR therapy. Interesting, CD22 antigen escape was also seen in these B-ALL patients. In preclinical models, high antigen density was associated with optimal CAR T cell response, however the role of antigen density's impact on clinical response has not been fully investigated. This CD22-CAR therapy has yet to be evaluated in refractory DLBCL patients and the role of CD22 antigen density's impact on response and relapse is unknown. Based on these observations, Dr. Frank, an Instructor in the Division of Blood and Marrow Transplantation at Stanford University, has proposed in his K08 application to investigate novel CAR therapies in DLBCL patients while undergoing an intensive training program to prepare him to launch an independent translational research program. Dr. Frank's training plan focuses on developing additional skills in clinical trial design and management; and in gaining advanced expertise in immunology and bioinformatic methods. This training will nicely harmonize with his three research aims. He proposes to conduct a Phase I trial investigating the safety and efficacy of this CD22-CAR therapy in patients with refractory DLBCL. Second, he wishes to determine whether surface antigen density impacts clinical response and relapse for patients receiving CD22- CAR therapy and whether antigen evasion can be mitigated by a bispecific CD19/CD22-CAR therapy, currently being investigated in DLBCL patients. Third, he desires to investigate how CAR T therapy influences circulating tumor DNA (ctDNA) dynamics in patients undergoing CD22-CAR and CD19/CD22-CAR therapy to optimize post-treatment surveillance strategies. As part of this third aim, he proposes to use a Stanford- developed ctDNA technology, CAPP-Seq, to identify mutations associated with CAR therapy resistance. To oversee Dr. Frank's training and research, he will be mentored by Drs. Crystal Mackall and David Miklos, leading experts in CAR T cell therapy. In addition, Dr. Frank has recruited Dr. Ronald Levy, a world-renowned leader in lymphoma and immune-based therapies, and Dr. Ash Alizadeh, a leading expert in ctDNA technologies, to serve as advisors and potential collaborators in his training and in accomplishing his aims. In carrying out his proposed research and training plan under the guidance of outstanding mentorship, Dr. Frank will be equipped to compete for R01 level of funding, publish high-level papers, and to launch an independent career leading a translational research program.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$8 )
2025	2024	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	5	6/26/2025	NON-COMPETING CONTINUATION	-$8
														Subtotal = -$8

Issue Date FY: 2024 ( Subtotal = $168,978 )
2024	2024	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	5	3/7/2024	NON-COMPETING CONTINUATION	$168,978
														Subtotal = $168,978

Issue Date FY: 2023 ( Subtotal = $168,978 )
2023	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	4	4/3/2023	NON-COMPETING CONTINUATION	$168,978
														Subtotal = $168,978

Issue Date FY: 2022 ( Subtotal = $168,978 )
2022	2022	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	3	5/3/2022	NON-COMPETING CONTINUATION	$168,978
														Subtotal = $168,978

Issue Date FY: 2021 ( Subtotal = $168,978 )
2021	2021	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	2	3/17/2021	NON-COMPETING CONTINUATION	$168,978
														Subtotal = $168,978

Issue Date FY: 2020 ( Subtotal = $168,978 )
2020	2020	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Cancer Research Manpower	000	1	3/9/2020	NEW	$168,978
														Subtotal = $168,978

Grand Total All Awards = $844,882

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Lymphoma Antigen Density and Circulating Tumor DNA Profiling As Determinants of Novel CAR Therapies

Award Number: K08CA248968

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 03/09/2020

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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