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

NCT07220993 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: H-57819 - NEO CRIMSON
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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 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 anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Conditions

T-cell Acute Lymphoblastic Lymphoma; T-non-Hodgkin Lymphoma; T-cell Acute Lymphoblastic Leukemia

Keywords

Autologous CAR T cells; T-cell acute lymphoblastic lymphoma; T-non-Hodgkin lymphoma; T-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity rate

  Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 5.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions.

  4 weeks

Secondary Outcomes (1)

• Overall Response Rate

  4 weeks

Study Arms (1)

CD7.CAR/28zeta T Cells

EXPERIMENTAL

Four dose levels will be evaluated. The T cells will be administered following lymphodepleting chemotherapy with cyclophosphamide and fludarabine.

Genetic: CD7.CAR/28zeta T Cells

Interventions

CD7.CAR/28zeta T Cells GENETIC

Fourdose levels will be evaluated: Dose level one: 1×10\^7 cells/m\^2 Dose level two: 3×10\^7 cells/m\^2 Dose level three: 5x10\^7 cells/m\^2 Dose level four: 1×10\^8 cells/m\^2

CD7.CAR/28zeta T Cells

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rayne Rounce, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• LaQuisa Hill, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rayne Rouce

CONTACT

832-824-4716; rhrouce@txch.org

LaQuisa Hill, MD

CONTACT

832-824-4670; LaQuisa.Hill@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 27, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2043
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (2)