RECRUITING

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Conditions

T-Cell Acute Lymphoblastic Leukemia/Lymphoma CART T-cell leukemia T-cell lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.

Official Title

A Phase 1 Study of Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-cell Lymphoblastic Lymphoma (T-LLy)

Quick Facts

Study Start:2025-04-29

Study Completion:2031-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06934382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 29 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Ages 0 to 29 years. 2. T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically: * Second or greater relapse or post-transplant relapse, defined as: * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR * Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR * Biopsy confirmed evidence of relapsed T-LLy after second CR; OR * Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy * Refractory disease, defined as: * Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy- or MRD-confirmed evidence of residual T-ALL or T-LLy; OR * Relapsed, refractory disease, defined as \> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR 3. Documentation of CD7 expression on leukemic blasts (defined as at least 20% of blasts positive for CD7 by flow cytometry or immunohistochemistry). 4. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy 5. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center. 6. Lansky Performance Status (ages \< 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50. 7. Patients of childbearing potential must have a negative urine or serum pregnancy test at screening. 8. Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion. 9. Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements.	1. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 2. Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy. 3. Receipt of prior CD7 targeted therapy. 4. Systemic antileukemic therapy intended to induce remission within 14 days prior to completion of screening. 5. Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease. 6. Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable. 7. Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening). 8. Evidence of organ dysfunction including: * Serum ALT ≥ 5 × ULN for age * Total bilirubin ≥ 3 × ULN for age * Serum creatinine that exceeds the maximum values listed in the protocol. * Any of the following cardiac criteria: * A minimum level of pulmonary reserve defined as \>Grade 1 dyspnea and \>Grade 3 hypoxia; DLCO 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the investigator 9. Positive serology for: * Human immunodeficiency virus (HIV) (HIV-1 or HIV2) * Human T-cell lymphotropic virus (HTLV) (HTLV-1 or HTLV-2) * Hepatitis B (positive surface Ag or positive core Ab unless Hep B DNA negative by polymerase chain reaction \[PCR\]) * Hepatitis C (if hepatitis C virus \[HCV\] antibody positive) must be HCV RNA PCR negative. Patients with sustained viral response \> 12 weeks following antiviral therapy are eligible as long as no history of hepatic cirrhosis is present. 10. Uncontrolled, active bacterial, viral, or fungal infection. 11. Any other condition that would make the patient ineligible for HSCT as determined by the investigator. 12. Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months. 13. Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL/T-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency. 14. Known primary immunodeficiency or BM failure syndrome. 15. Pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

1. Ages 0 to 29 years.
2. T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically:
* Second or greater relapse or post-transplant relapse, defined as:
* BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR
* Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR
* Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR
* Biopsy confirmed evidence of relapsed T-LLy after second CR; OR
* Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy
* Refractory disease, defined as:
* Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy- or MRD-confirmed evidence of residual T-ALL or T-LLy; OR
* Relapsed, refractory disease, defined as \> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR
3. Documentation of CD7 expression on leukemic blasts (defined as at least 20% of blasts positive for CD7 by flow cytometry or immunohistochemistry).
4. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy
5. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.
6. Lansky Performance Status (ages \< 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50.
7. Patients of childbearing potential must have a negative urine or serum pregnancy test at screening.
8. Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion.
9. Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements.

1. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
2. Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.
3. Receipt of prior CD7 targeted therapy.
4. Systemic antileukemic therapy intended to induce remission within 14 days prior to completion of screening.
5. Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.
6. Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable.
7. Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).
8. Evidence of organ dysfunction including:
* Serum ALT ≥ 5 × ULN for age
* Total bilirubin ≥ 3 × ULN for age
* Serum creatinine that exceeds the maximum values listed in the protocol.
* Any of the following cardiac criteria:
* A minimum level of pulmonary reserve defined as \>Grade 1 dyspnea and \>Grade 3 hypoxia; DLCO 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the investigator
9. Positive serology for:
* Human immunodeficiency virus (HIV) (HIV-1 or HIV2)
* Human T-cell lymphotropic virus (HTLV) (HTLV-1 or HTLV-2)
* Hepatitis B (positive surface Ag or positive core Ab unless Hep B DNA negative by polymerase chain reaction \[PCR\])
* Hepatitis C (if hepatitis C virus \[HCV\] antibody positive) must be HCV RNA PCR negative. Patients with sustained viral response \> 12 weeks following antiviral therapy are eligible as long as no history of hepatic cirrhosis is present.
10. Uncontrolled, active bacterial, viral, or fungal infection.
11. Any other condition that would make the patient ineligible for HSCT as determined by the investigator.
12. Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months.
13. Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL/T-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency.
14. Known primary immunodeficiency or BM failure syndrome.
15. Pregnant or breastfeeding.

Contacts and Locations

Study Contact

Cell Therapy Intake Team

CONTACT

445-942-5891

CART_NurseNavigator@chop.edu

Melissa S Varghese, B.A.

CONTACT

845-553-5358

varghesem@chop.edu

Principal Investigator

Caroline Diorio, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Stephan Grupp, MD, PhD

STUDY_DIRECTOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Stephan Grupp MD PhD

Caroline Diorio, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
Stephan Grupp, MD, PhD, STUDY_DIRECTOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29

Study Completion Date2031-05-30

Study Record Updates

Study Start Date2025-04-29

Study Completion Date2031-05-30

Terms related to this study

Keywords Provided by Researchers

CART
T-cell leukemia
T-cell lymphoma

Additional Relevant MeSH Terms

T-Cell Acute Lymphoblastic Leukemia/Lymphoma