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Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells

RecruitingPhase 1Ages any - 75 YearsAllBaylor College of Medicine
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In plain words

What the trial is, and whether it could suit you

Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called a

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Procurement Inclusion Criteria: • Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), 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 leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)) AND Relapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT from whom allogeneic CD7.CAR T cells can be manufactured. AND * suitable for allogeneic hematopoietic stem cell transplant (HSCT) * with a suitable donor identified by a FACT accredited transplant center * willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates. Using NMDP donor assessment criteria, suitability is defined as "during the search process, a donor is fit to proceed to the next step- whether high-resolution or confirmatory HLA testing OR donor work-up." Documentation of suitability will be confirmed by the investigator prior to treatment. \*For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated. * CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). * Age ≤75 years old. * Hgb ≥ 7.0 g/dL (can be transfused) * Life expectancy greater than 12 weeks * Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation. * Informed consent explained to, understood by and signed by patient/LAR. Patient/LAR given copy of informed consent. Procurement Exclusion Criteria: * Active infection requiring antibiotics * Active infection with HIV * History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry. Prior HSCT Donor Procurement Criteria: • Donor must be prior hematopoietic stem cell transplant donor for patient relapsed post-allogeneic HSCT who meets patient screening eligibility criteria and has signed screening informed consent. Prior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and testing for infectious disease markers (IDMs; which may be pending at the time of blood collection). Medical history may be obtained by the patient's primary/referring transplant team if collection is being done remotely. The physician assessment, donor questionnaire, and IDMs will be reviewed by the principal investigator or appropriate designee to confirm/provide final eligibility determination and documented in the donor's medical record. • Informed consent explained to, understood by and signed by donor/LAR. Donor/LAR given copy of informed consent. Treatment Inclusion Criteria: • Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), 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 leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)) AND Relapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT AND prior allogeneic donor available to donate blood for allogeneic CD7.CAR T-cell manufacture AND * suitable for allogeneic hematopoietic stem cell transplant (HSCT) * with a suitable donor identified by a FACT accredited transplant center * willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates. Using NMDP donor assessment criteria, suitability is defined as "during the search process, a donor is fit to proceed to the next step- whether high-resolution or confirmatory HLA testing OR donor work-up." Documentation of suitability will be confirmed by the investigator prior to treatment. \*For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated. * CD7-positive tumor (≥20% CD7+ blasts or tumor cells by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified Flow Cytometry/Pathology laboratory. * Age ≤75 years old. * Bilirubin less than 3 times the upper limit of normal. * AST less than 5 times the upper limit of normal. * Estimated GFR ≥ 50 mL/min. * Pulse oximetry of \> 90% on room air * Karnofsky or Lansky score of ≥ 60%. * Recovered from acute toxic effects of prior treatments (i.e. chemotherapy) at least one week before entering this study. * ≥ 60 days post-allogeneic HSCT at time of treatment. * Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation. * 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. The male partner should use a condom. * Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent. Treatment Exclusion Criteria: * Currently receiving any investigational agents or having received any tumor vaccines within the previous 4 weeks. * History of hypersensiti
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What it tests

  • CD7.CAR/28zeta T Cells
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Where

2 sites
Houston Methodist Hospital
Houston, United States
Texas Children's Hospital
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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