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

NCT06934382 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 24CT015, 25-023121, BTX-ALT-00
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T-Cell Acute Lymphoblastic Leukemia/Lymphoma

Keywords

CART; T-cell leukemia; T-cell lymphoma

Outcome Measures

Primary Outcomes (2)

• Determine the Maximum Tolerate Dose of Beam 201 Cells

  The Maximum Tolerated Dose will be determined by measuring the incidence of dose limiting toxicities following administration of the product.

  5 years

• Frequency of Adverse Events Following Beam-201 administration

  Frequency of Adverse events will be measured by evaluating the frequency and severity of treatment related adverse events following administration of Beam-201 Cells

  5 years

Secondary Outcomes (5)

• • Determine the overall response rate following BEAM-201 infusion

  5 years

• Determine depth of response based on MRD for patients with clinical responses following BEAM-201 infusion

  5 years

• Determine the proportion of patients treated with BEAM-201 who are deemed appropriate for stem cell transplant

  5 years

• • Determine duration of response for patients with clinical responses following BEAM 201 infusion

  5 years

• Determine overall survival following BEAM-201 infusion

  5 years

Study Arms (2)

Dose Escalation Arm

EXPERIMENTAL

The dose escalation portion of the trial will use a standard "3+3" design to establish the recommended maximum tolerated dose of BEAM-201 cells. Three dose escalations of BEAM-201 are planned for the dose escalation phase, with one dose de-escalation level if needed.

Biological: Allogeneic anti-CD7 CAR-T cells (BEAM-201)

Dose Expansion Arm

EXPERIMENTAL

If at least one dose level of the dose escalation phase is determined to be safe, the dose expansion phase of the trial will be opened to enrollment.

Biological: Allogeneic anti-CD7 CAR-T cells (BEAM-201)

Interventions

Allogeneic anti-CD7 CAR-T cells (BEAM-201) BIOLOGICAL

The investigational agent in this protocol is allogeneic anti-CD7 CART cells (BEAM-201). BEAM-201 is comprised of allogeneic anti-CD7 CAR-T cells edited by 4 gRNAs and a single mRNA encoding a CBE, then transduced with a lentiviral vector (LVV) encoding the anti-CD7 chimeric antigen receptor (CAR) molecule.

Also known as: BEAM-201

Dose Escalation Arm; Dose Expansion Arm

Eligibility Criteria

• Age: 0 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Patients who meet any of the following criteria will be disqualified from entering the study:
• Active hepatitis B or active hepatitis C
• Active HTLV infection
• HIV infection
• Uncontrolled, active bacterial, viral, or fungal infection.
• CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
• Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.
• Receipt of prior CD7 targeted therapy.
• Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.
• 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.
• Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).
• Any other condition that would make the patient ineligible for HSCT as determined by the investigator.
• Known primary immunodeficiency or BM failure syndrome.
• Atrial fibrillation/flutter (not including isolated episodes that responded to medical management)
• Clinically significant pericardial effusion

Sponsors & Collaborators

• Stephan Grupp MD PhD: lead
• Beam Therapeutics Inc.: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma; Leukemia, T-Cell; Lymphoma, T-Cell

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; Lymphoma, Non-Hodgkin

Study Officials

• Caroline Diorio, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Stephan Grupp, MD, PhD

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Central Study Contacts

Cell Therapy Intake Team

CONTACT

445-942-5891; CARTNurseNavigator@chop.edu

Melissa S Varghese, M.S.

CONTACT

845-553-5358; varghesem@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Cell Therapy and Transplant Section Director, Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy Medical Director, Cell and Gene Therapy Lab

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2031
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)