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Not yet recruitingNCT07575893REACH-CD30Updated May 20, 2026

CD30 CAR-T Cells for Low Risk Relapsed Classical Hodgkin Lymphoma

A Phase 1 interventional study of CD30+ CAR T-cells and Bendamustin in Classical Hodgkin Lymphoma, sponsored by New York Medical College. Not yet recruiting. Open to participants aged 6 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by New York Medical College · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
6 Years to 29 Years
Sex
All
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Study summary

Patients with relapsed low-risk CD30 classical Hodgkin Lymphoma will have autologous CD30 CAR T-cell manufactured. Dose escalation will be used to determine the RP2D. Following lymphodepletion, CAR T-cell will be infused.

Read the detailed description

Patients will have autologous cell collected and they will be manufactured for CD30 CAR T-cells. Following reinduction therapy for relapsed cHL, patients with a good response will receive lymphodepletion therapy and infusion of the CAR T-cells 1-14 days after. We incorporated a dose escalation plan to determine the RP2D. There will be a dose-expansion cohort to collect further safety and manufacturing data.

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Conditions studied

  • Classical Hodgkin Lymphoma
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In context

Lead sponsor

New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
  2. Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.
  3. Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry.
  4. Risk Factors: Patient must meet established low-risk factors:

    Stage at Diagnosis = IA, IIA

    • 12 months from end of therapy OR 3-12 months from end of therapy with ≤3 cycles of treatment and no radiation NO B symptoms NO extra nodal disease at relapse NO relapse in a prior radiation field Stage at Diagnosis = IB, IIB, IIIA
    • 12 months from end of therapy NO B symptoms NO extranodal disease at relapse NO relapse in a prior radiation field
  5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label.
  6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.
  7. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  8. Subject is willing and able to comply with study procedures based on the judgement of the investigator.
  9. Planned to undergo reinduction therapy and found to have a favorable response to one line of reinduction therapy. Patients who are refractory to initial reinduction attempts are considered high-risk and thus not eligible for Cell Product Administration and will be removed from study.

Exclusion criteria

Exclusion:

  1. High-risk relapsed classical Hodgkin Lymphoma with any of the following:

    B symptoms extra nodal disease at relapse relapse in a prior radiation field

  2. Patients under 6 years and over 29 years of age.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    CD30+ CAR T-cells

    Patients will receive infusion of autologous CD30+ CAR T-cells previously manufactured following lymphoma depletion with bendamustine and fludarabine. Dose will vary until RP2D determined.

    Biological: CD30+ CAR T-cells · Drug: Bendamustin · Drug: Fludarabine

Interventions

  • BiologicalCD30+ CAR T-cells

    patients with cHL with a good response following reinduction therapy will receive autologous CD30 CAR T-cells 1-14 days following lymphodepletion

    Also known as: ALTCAR.30

  • DrugBendamustin

    Patients will receive 70 mg/m2/day × 3 days prior to CD30 CAR T-cells

  • DrugFludarabine

    Patients will received 30 mg/m2/day × 3 days prior to CD30 CAR T-cells.

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What researchers measure

Primary outcomes

  1. To determine the RP2D of CD30 CAR T-cells

    dose escalation will occur for the CD30 CAR T-cells to determine optimal dose with no DLTs.

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07575893
Lead sponsor
New York Medical College
Collaborators
University of North Carolina, Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 1, 2031 (estimated)
Completion
Dec 1, 2032 (estimated)
Last update
May 20, 2026

Study contacts

Mitchell S Cairo, MD
Contact
mcairo@nymc.edu
914-594-2150
Lauren Harrison, MSN
Contact
lauren_harrison@nymc.edu
617-285-7844
Mitchell Cairo, MD
principal investigator · New York Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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