Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07297160
Eligibility Criteria:
PROCUREMENT INCLUSION CRITERIA:
• 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
OR
Patients with relapsed/refractory Renal Cell Carcinoma (RCC) OR sarcomas (for sarcoma only patients age 25 or younger are eligible)
OR
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.
PROCUREMENT EXCLUSION CRITERIA:
* 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).
TREATMENT INCLUSION CRITERIA:
• 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
OR
Patients with relapsed/refractory Renal Cell Carcinoma (RCC) or sarcomas (for sarcoma only patients age 25 or younger are eligible)
OR
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
* Pulse oximetry of \> 90% on room air
* Karnofsky or Lansky score of ≥60%
* Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. Male partner should use a condom.
* Informed Consent Obtained.
TREATMENT EXCLUSION CRITERIA:
* Received investigational anti-cancer agents \< 28 days or 5 half-lives, whichever is shorter
* Received any tumor vaccines within the previous 6 weeks
* Pregnant or lactating
* Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \>350 mm3.
* Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.
* Cardiac abnormalities: Cardiac echocardiography with LVEF\<50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions must be obtained within 6 months of treatment.
* Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days
* Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days.
* Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD.
* High dose steroids \>1 mg/kg within the preceding 5 days or currently receiving \>0.5 mg/kg/day prednisone equivalent.
* Bulky CNS or mediastinal disease that significantly increases potential risks (e.g. airway obstruction, TIAN) in the estimation of a principal investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
75 Years
Study:
NCT07297160
Study Brief:
Protocol Section:
NCT07297160