Status:
NOT_YET_RECRUITING
Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Conditions:
T-cell Acute Lymphoblastic Lymphoma
T-non-Hodgkin Lymphoma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE1
Brief Summary
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 combine...
Detailed Description
Earlier, the patients previous bone marrow transplant donor gave the investigator blood to make CD7 CD28 chimeric receptor- T cells in the laboratory. These cells were grown and frozen for the patient...
Eligibility Criteria
Inclusion
- Procurement
- • 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2043
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT07220993
Start Date
December 1 2025
End Date
December 1 2043
Last Update
October 27 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030