Classical Hodgkin LymphomaPhase 1REACH-CD30NCT07575893
CD30 CAR-T Cells for Low Risk Relapsed Classical Hodgkin Lymphoma
A Phase 1 study testing CD30+ CAR T-cells, Bendamustin and Fludarabine in people with Classical Hodgkin Lymphoma, run by New York Medical College.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 29 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- CD30+ CAR T-cells, Bendamustin and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
- Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.
- Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry.
- 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
Show all 12Show fewer
- 12 months from end of therapy NO B symptoms NO extranodal disease at relapse NO relapse in a prior radiation field
- 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.
- 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.
- 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.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- 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.
Who cannot join
- High-risk relapsed classical Hodgkin Lymphoma with any of the following:
- B symptoms extra nodal disease at relapse relapse in a prior radiation field
- Patients under 6 years and over 29 years of age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REACH-CD30: Reinduction Therapy Followed by Engineered Autologous CD30.CAR T Cells in Children, Adolescents and Young Adults With Lower-Risk CD30+ Relapsed Classical Hodgkin Lymphoma NYMC 628
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.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- CD30+ CAR T-cells, Bendamustin, Fludarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD30+ CAR T-cellsBiological
Also called ALTCAR.30
patients with cHL with a good response following reinduction therapy will receive autologous CD30 CAR T-cells 1-14 days following lymphodepletion
BendamustinDrug
Patients will receive 70 mg/m2/day × 3 days prior to CD30 CAR T-cells
FludarabineDrug
Patients will received 30 mg/m2/day × 3 days prior to CD30 CAR T-cells.
| Study group | Role | What they receive |
|---|---|---|
| CD30+ CAR T-cells | Experimental | 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. Receives: Biological: CD30+ CAR T-cells; Drug: Bendamustin; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive therapy.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Mitchell Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575893
- Sponsor's protocol ID
- NYMC 628
- Acronym
- REACH-CD30
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH-CD30: Reinduction Therapy Followed by Engineered Autologous CD30.CAR T Cells in Children, Adolescents and Young Adults With Lower-Risk CD30+ Relapsed Classical Hodgkin Lymphoma NYMC 628
- ClinicalTrials.gov ID
- NCT07575893
- Acronym / sponsor ID
- REACH-CD30 / NYMC 628
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- University of North Carolina, Memorial Sloan Kettering Cancer Center
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive therapy.
| Arm | Type | Receives |
|---|---|---|
| CD30+ CAR T-cells | Experimental | Biological: CD30+ CAR T-cells, Drug: Bendamustin, Drug: FludarabinePatients will receive infusion of autologous CD30+ CAR T-cells previously manufactured following lymphoma depletion with bendamustine and fludarabine. Dose will vary until RP2D determined. |
Who may qualify
- Ages
- 6 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
- Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.
- Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry.
- Risk Factors: Patient must meet established low-risk factors:
- Stage at Diagnosis = IA, IIA
Key exclusion criteria (3 listed)
- High-risk relapsed classical Hodgkin Lymphoma with any of the following:
- B symptoms extra nodal disease at relapse relapse in a prior radiation field
- Patients under 6 years and over 29 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD30+ CAR T-cellsAlso: ALTCAR.30patients with cHL with a good response following reinduction therapy will receive autologous CD30 CAR T-cells 1-14 days following lymphodepletion | Biological | CD30+ CAR T-cells |
| BendamustinPatients will receive 70 mg/m2/day × 3 days prior to CD30 CAR T-cells | Drug | CD30+ CAR T-cells |
| FludarabinePatients will received 30 mg/m2/day × 3 days prior to CD30 CAR T-cells. | Drug | CD30+ CAR T-cells |
Primary outcome
To determine the RP2D of CD30 CAR T-cells
Time frame: 1 year
dose escalation will occur for the CD30 CAR T-cells to determine optimal dose with no DLTs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
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Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Cairo, MD principal investigator
New York Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD30+ CAR T-cells, Bendamustin and Fludarabine in people with Classical Hodgkin Lymphoma, run by New York Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell S Cairo, MD (914-594-2150, mcairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the RP2D of CD30 CAR T-cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.