FT836 / Fate Therapeutics - LARVOL DELTA

FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Medical College of Wisconsin | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

Preliminary phase 1 results of a MICA/B-targeted CAR T cell designed to overcome solid tumor escape mechanisms and avoid the requirement for conditioning chemotherapy. (ASCO 2026) - P1 | " The Phase 1 trial of FT836 in pts with advanced solid tumors (NCT07216105) evaluates multiple regimens including monotherapy (Regimen A), combination with EGFR-targeting mAb cetuximab or HER2-targeting mAb trastuzumab (Regimen C or E, respectively). FT836 Regimen C DL1 was well-tolerated and early clinical data supports anti-tumor activity in highly refractory mCRC where there is significant unmet need. This trial is actively enrolling and updated clinical and translational data will be presented."

CAR T-Cell Therapy • P1 data • Colorectal Cancer • Graft versus Host Disease • Immunology • Oncology • Solid Tumor • CD58 • CXCR2 • HER-2

CAR T cells Targeting pan-Tumor Antigens MICA/B can be Uniquely Combined with SOC Treatments without Conditioning Chemotherapy for Broad and Effective Therapeutic Application in Cancer (ASGCT 2026) - P1 | "Combining FT836 with clinically approved mAbs targeting, such as CD38, EGFR, or HER2 (e.g. Daratumumab, Cetuximab, or Herceptin, respectively) extended FT836 cytotoxicity, underscoring the flexibility of multi-antigen strategy in diverse tumor settings. Notably, FT836 can also be combined with SOC therapeutics such as the immunomodulatory drug (IMiD) Lenalidomide (MM; 74.9% CTL vs 92.6% CTL -/+ IMiD) or agents that specifically upregulate MICA/B expression (e.g. irradiation or chemotherapeutic agents such as Paclitaxel) for enhanced anti- tumor targeting in both liquid and solid tumors...Combination with mAbs or with chemotherapy enhanced the in vivo anti-tumor efficacy of FT836 in stress model settings (Trastuzumab vs. monotherapy, 99% vs 50% TGI (p<0.0001); daratumumab vs monotherapy, 99% vs. 75% TGI (p=0.06); Paclitaxel vs. monotherapy, 61% vs 28% TGI (p<0.0001))...Conclusion The preclinical data demonstrates that FT836 has the potential to mediate potent..."

CAR T-Cell Therapy • IO biomarker • Pan tumor • Acute Lymphocytic Leukemia • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Graft versus Host Disease • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Leukemia • Multiple Myeloma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CD58 • CXCR2 • EGFR • HER-2 • MICA • MICB

Fate Therapeutics…presenting data this week featuring its off-the-shelf CAR T-cell programs…FT836 at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026 (GlobeNewswire) - "Preclinical data for FT836 shows effective elimination of broad range of cancers in synergy with SOC treatments; radiotherapy and chemotherapy significantly enhance FT836 cytolytic activity and specific trafficking to the tumor site"

Preclinical • Solid Tumor

FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Medical College of Wisconsin | Initiation date: Mar 2026 ➔ Jul 2026

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

FT836 demonstrates clinical activity in CRC without the use of conditioning chemotherapy. (GlobeNewswire) - "As of the January 23rd 2026 data cut off, one of the three CRC patients treated in combination with cetuximab at DL1, a heavily pretreated 45 year old male who was refractory to cetuximab and had received 7 prior lines of therapy, demonstrated early evidence of anti-tumor activity, including a greater than 50% reduction in carcinoembryonic antigen (CEA) levels and significant reduction in lactate dehydrogenase (LDH) levels at Day 29 post treatment, with tumor reduction seen across all target lesions of approximately 20% decrease in the sum of diameters at the 46-day evaluation scan....The Company expects to provide additional clinical data updates in the second half of 2026."

P1 data • Colorectal Cancer

Targeting of tumor antigen CD38 and stress antigens MICA/B by CAR T cells provides a unique approach for the comprehensive treatment of multiple myeloma (ASH 2025) - "Introduction:Recently approved autologous chimeric antigen receptor (CAR) T-cell therapies (Abecma® and Carvykti®)have demonstrated clear clinical benefit for patients with relapsed/refractory multiple myeloma (MM)with initial response rates ranging between 73-98%...The uniqueengineered elements of FT836 further enable (i) multi-antigen targeting by antibody-dependent cellularcytotoxicity (ADCC) in combination with the high-affinity non-cleavable CD16a Fc receptor (hnCD16) andtherapeutic monoclonal antibodies (e.g. sarclisa and daratumumab), (ii) functional persistence in anallogeneic setting without the reliance on conditioning chemotherapy using dual Sword and ShieldTMengineering, incorporating a synthetic alloimmune defense receptor (ADR) that selectively eliminates 4-1BB+ alloreactive immune cells and genetic deletion of CD58 to avoid recognition by host immune cells,and (iii) improved tumor homing and resistance to immunosuppression via expression of the..."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • CD58 • CXCR2 • FCGR3A • NKG2D

Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a comprehensive approach to treatment of multiple myeloma (GlobeNewswire)

Preclinical • Multiple Myeloma

Next-generation Off-the-Shelf CAR T-cell Programs with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy (Fate Therapeutics Press Release) - "In parallel, non-clinical datasets underscoring broad solid tumor indication applicability, in combination with multi-antigen targeting, augmented tumor micro-environment adaptation, enhanced allo-protection via Sword and Shield technology, and ability of FT836 to be administered in the absence of conditioning chemotherapy were recently presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025). The Company plans to present a complimentary dataset establishing the utility of FT836 against multiple myeloma in combination with daratumumab and/or standard of care therapy at the 67th American Society of Hematology (ASH) Annual Meeting."

P1 data • Trial status • Solid Tumor

Next-generation off-the-shelf CAR T cell targeting pan-tumor antigen MICA/B and engineered with immune evasion enables treatment across solid tumors without the need for conditioning chemotherapy (SITC 2025) - "Moreover, the activity and durability of response was further enhanced with the combination of mAb in various stress tumor models. Treatments combining FT836 with chemotherapy, radiotherapy, or antibody-drug conjugates enhanced MICA/B expression on tumor cells, further improving CAR-mediated anti-tumor responses.In serial tumor challenge experiments conducted in base culture or allogeneic environment, the ADR and CD58 knockout edits uniquely enabled sustained functionality and persistence of FT836 even with exposure to alloreactive immune cell attack (figure 2).Conclusions FT836 is a multiplexed engineered, off-the-shelf CAR T-cell therapy targeting the α3 domain of MICA/B, offering applicability across multiple solid tumor types without the need for CCT to facilitate broader clinical application and overcome multiple challenges that limit adoptive cell therapies in treating solid tumor.Abstract 264 Figure 1Request permissionsFT836 demonstrates broad and potent..."

CAR T-Cell Therapy • IO biomarker • Pan tumor • Cervical Cancer • Oncology • Solid Tumor • CD58 • EGFR • HER-2 • MICA • MICB

FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=113 | Recruiting | Sponsor: Fate Therapeutics

New P1 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "In July, the FDA allowed the Company’s investigational new drug (IND) application to initiate Phase 1 clinical testing of FT836....The Phase 1 study is designed to assess the safety and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors."

IND • New P1 trial • Solid Tumor

FT836, a Novel MICA/B-targeting CAR T-cell Therapy Engineered to Eliminate the Need for Conditioning Chemotherapy with Broad Activity Across Solid Tumor Indications (ASGCT 2025) - "Notably, combination with chemotherapy, radiotherapy, or antibody drug conjugates, such as trastuzumab-deruxtecan, increased MICA/B expression on tumor cells and enhanced FT836 CAR-mediated anti-tumor activity. As a result, FT836 is uniquely equipped to eliminate the need for conditioning chemotherapy, facilitating broader clinical application both as monotherapy and in combination with standard-of-care agents such as chemotherapy and therapeutic monoclonal antibodies, overcoming multiple challenges that limit adoptive cell therapies in treating solid tumor. Disease Focus of Abstract:Cancer Solid Tumors"

CAR T-Cell Therapy • IO biomarker • Cervical Cancer • Infectious Disease • Oncology • Solid Tumor • CD58 • EGFR • MICA • MICB • NKG2D

Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "Next-generation iPSC-derived CAR T-cell Programs: (i) FT836 MICA/B-targeted CAR T-cell Program:...At the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting being held in New Orleans on May 13-17, the Company plans to present preclinical data showing that FT836 exerted potent and durable anti-tumor activity in vivo across a broad array of solid tumors....In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836."

Financing • Preclinical • Solid Tumor

Development of an off-the-shelf, MICA/B-targeted CAR T cell to overcome a pan-tumor escape mechanism for solid tumors (SITC 2024) - "Combination with chemotherapy, radiotherapy, or antibody drug conjugates, such as trastuzumab-deruxtecan, increased MICA/B expression on tumor cells and enhanced FT836 anti-tumor activity. In preclinical studies, FT836 demonstrates anti-tumor activity in the presence of allogeneic immune cells, suggesting that it may be effectively combined with standard-of-care agents in the absence of conditioning chemotherapy. Ethics Approval These studies were approved by Fate Therapeutics Institutional Animal Care and Use Committee and were carried out in accordance with the National Institutes of Health's Guide for the Care and Use of Laboratory Animals."

CAR T-Cell Therapy • IO biomarker • Pan tumor • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CD58 • CD8 • CXCR2 • EGFR • FCGR3A • MICA • MICB • NKG2D

Fate Therapeutics Presents Pan-tumor Targeting Preclinical Data for FT836 MICA/B-targeted CAR T-cell Product Candidate at 2024 SITC Annual Meeting (GlobeNewswire) - "At an oral presentation today at SITC entitled 'Development of an Off-the-Shelf, MICA/B Targeting CAR T Cell to Overcome Pan-tumor Escape Mechanism for Solid Tumors', scientists from the Company highlighted that FT836 exerted potent and durable anti-tumor activity in vivo across a broad array of solid tumors. In addition, treatment of tumor cells with chemotherapy or radiation therapy in vitro elicited an increase in MICA/B expression and further enhanced the cytolytic activity of FT836, indicating the potential for combination with standard-of-care regimens used for the treatment of solid tumors."

Preclinical • Solid Tumor