CD70.CAR for CD70+ Lymphoma, Myeloma and Solid Tumors
CALySSEY
Chimeric Antigen Receptor Treatment Targeting Lymphoma, Myeloma and Solid Tumors That Express CD70 (SEventY) CALySSEY
1 other identifier
interventional
88
1 country
2
Brief Summary
This study is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer has come back or has not gone away after standard of care treatment. As there are limited or no remaining standard treatments available to treat this cancer, patients are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the tumor cells in the body. This research study combines different ways of fighting disease by using T cells and "arming" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients. The protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to tumor cells when it binds to CD70. CD70 binders have been used to treat people with different types of cancers. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When binder is joined to a T cell in this way it is called a chimeric receptor or "CAR T cell". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the "CAR T cells" to kill blood cancer cells which are confirmed to have CD70. In the laboratory, investigators have found that T cells work better if there are proteins added that stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on tumor cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the tumor cells. These CD70 "CAR" T cells are investigational products not approved by the Food and Drug Administration. The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with lymphoma (lymph gland cancer), myeloma and certain solid tumors including some sarcomas and kidney cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lymphoma
Started Jun 2026
Longer than P75 for phase_1 lymphoma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
Study Completion
Last participant's last visit for all outcomes
December 1, 2044
March 4, 2026
March 1, 2026
3.5 years
December 9, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose limiting toxicity (DLT) rate
Toxicity for all patients will be evaluated using the NCI Common Toxicity Criteria Scale with the exception of CRS and immune effector cell associated neurotoxicity (ICANS). CRS and ICANS will be graded per ASTCT consensus grading criteria.
4 weeks post infusion
Secondary Outcomes (1)
Overall response rate
6-8 weeks post infusion
Study Arms (2)
Treatment Arm A - Lymphoma and Solid Tumors
EXPERIMENTALCD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with lymphoma and solid tumors. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.
Treatment Arm B - Myeloma
EXPERIMENTALCD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with myeloma. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.
Interventions
Dose Level 2: 3 x 10\^6 cells/kg
Dose Level 3: 1 x 10\^7 cells/kg
Dose Level -1: 3 x 10\^5 cells/kg
Dose Level 1 (starting dose level): 1 x 10\^6 cells/kg
Eligibility Criteria
You may qualify if:
- Diagnosis of relapsed/refractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes, Extranodal NK/T cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma
- Patients with relapsed/refractory Renal Cell Carcinoma (RCC) OR sarcomas (for sarcoma only patients age 25 or younger are eligible)
- Patients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy ("triple class refractory")
- (3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).
- CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (staining can be pending at time of procurement)
- Age ≤75 years (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- If apheresis required to collect blood, PT and aPTT \<1.5x ULN; Serum Creatinine \< 2 x ULN; AST \< 5 x ULN.
You may not qualify if:
- Active infection (bacterial, fungal or viral) requiring ongoing treatment without improvement.
- Known active infection with HIV or HTLV (collected blood will be sent for HIV/HTLV testing, separate testing prior to procurement not required). Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \>350 mm3.
- Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment
- Ongoing treatment with immune suppression for prophylaxis/treatment of GVHD including high dose steroids (e.g., prednisone \> 0.5 mg/kg/day).
- Diagnosis of relapsed/refractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes), , Extranodal NK/T cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma
- Patients with relapsed/refractory Renal Cell Carcinoma (RCC) or sarcomas (for sarcoma only patients age 25 or younger are eligible)
- Patients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy ("triple class refractory") and also failed or ineligible for anti-BCMA therapies.
- (3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).
- CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (tissue)
- No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment
- Age ≤75 years. (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age).
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- Total bilirubin \< 3 times the upper limit of normal
- AST/ALT \< 5 times the upper limit of normal
- Creatinine \< 2 times the upper limit of normal
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Texas Children's Hospital
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bilal Omer, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- None (Open Label)
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 9, 2025
First Posted
December 22, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2044
Last Updated
March 4, 2026
Record last verified: 2026-03