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CD4 Redirected Chimeric Antigen Receptor T Cell Therapy for CD4 Positive T Cell Neoplasms

Award Number: R01FD006820
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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CD4 Redirected Chimeric Antigen Receptor T Cell Therapy for CD4 Positive T Cell Neoplasms - Project summary/abstract This is a phase I, 3+3 dose escalation, first in man, clinical trial to study CD4 Redirected Chimeric Antigen Receptor T Cell Therapy (CD4CAR) for CD4 Positive T cell heavily pretreated or refractory patients with CD4+ T cell malignancies. The investigational agent to be studied are autologous CD4CAR T-cells engineered to express an anti-CD4scFV domain derived from the monoclonal antibody (mAb) Ibalizumab (Hu5A8 or TNX-355) paired with an intracellular tyrosine-based activation motif from the T-cell receptor (TCR) and two costimulatory domains, CD28 and 4BB via lentiviral transduction in a good manufacturing practice (GMP) clean facility. We plan to enroll up to 30 patients in order to treat ̴15 subjects (accounting for screen and manufacturing failures) with CD4CAR. Eligible subjects are patients with relapsed or refractory CD4 positive T cell lymphoma and leukemia to second line standard therapy. The primary objective of the clinical trial is to test the feasibility to manufacture and the safety of CD4CAR cells in this patient population. Subjects will be screened and entered into the study if eligible. Subjects will then be conditioned with cytoreductive chemotherapy using cyclophosphamide and fludarbine for lymphodepletion. After meeting release criteria CD4CAR autologous cells will be administered over a short infusion time. Patients will be hospitalized for the period of infusion and till expected serious side effects are resolved. Major side effects include cytokine release syndrome and neurotoxicity, accelerated CAR proliferation, and generation of replication capable lentivirus. As well as infections related to CD4-deplete host. Strict prophylaxis and monitoring for early treatment for all of those will be implemented. Study subjects will be monitored closely during and after discharge from hospital with physical exams, lab work, CAR T persistence testing and end organ toxicity. Description of objective responses will be recorded. This is a high risk study with long follow up (up to 15 years).


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 = $756,574 )
2025	2025	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	000	5	7/21/2025	NON-COMPETING CONTINUATION	$756,574
														Subtotal = $756,574

Issue Date FY: 2024 ( Subtotal = $788,134 )
2024	2024	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	000	4	8/5/2024	NON-COMPETING CONTINUATION	$788,134
														Subtotal = $788,134

Issue Date FY: 2023 ( Subtotal = $787,515 )
2023	2023	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	001	3	6/21/2023	NON-COMPETING CONTINUATION	$787,515
2023	2020	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	000	2	3/22/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $787,515

Issue Date FY: 2022 ( Subtotal = -$1 )
2022	2020	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	002	2	6/29/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2020	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	001	2	5/25/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$526,876
2022	2020	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	004	2	7/21/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2020	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	WEST 5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Food and Drug Administration Research	000	1	5/4/2022	NEW	-$526,876
2022	2020	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Food and Drug Administration Research	005	2	7/25/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2020	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	W5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Food and Drug Administration Research	003	1	7/8/2022	NEW	-$1
														Subtotal = -$1

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	WEST 5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Food and Drug Administration Research	000	1	7/12/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $786,909 )
2020	2020	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	WEST 5510 FRANKS MELVILLE MEMORIAL LIBRARY	STONY BROOK	NY	11794	SUFFOLK	USA	Food and Drug Administration Research	000	1	9/25/2020	NEW	$786,909
														Subtotal = $786,909

Grand Total All Awards = $3,119,131

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CD4 Redirected Chimeric Antigen Receptor T Cell Therapy for CD4 Positive T Cell Neoplasms

Award Number: R01FD006820

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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