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RecruitingNCT06218602Updated Aug 17, 2026

Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.

A Phase 2 interventional study of Fecal Microbiota Transplantation and Chemotherapy in Lymphoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.

Read the detailed description

Primary Objectives

  1. To assess the toxicity of combination of FMT with anti-CD19 Axicabtagene ciloleucel therapy and compare it with standard of care Arm B with anti-CD19 CAR-T arm
  2. To assess the response in participants treated with the combination of FMT and Axicabtagene ciloleucel CAR T-cell therapy at day 30 and compare it with standard of care Arm B with anti-CD19 CAR-T arm.

Secondary Objectives

  1. To assess PFS and OS among participants with and without FMT.
  2. To assess changes in gut microbiome of lymphoma participants after FMT.
  3. To assess dynamic changes in serum and stool metabolites after FMT.
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Conditions studied

  • Lymphoma

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03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. At least 18 years of age on the day of signing informed consent.
  2. Histologically/cytologically confirmed diagnosis of B-cell lymphomas.
  3. Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.
  4. Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam.
  5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of signing study consent.
  6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  7. Absolute neutrophil counts should be greater than 1000/ul at the time of administration of fecal enema.
  8. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed], an AST, level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN
  9. Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.
  10. Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first study-drug administration, for the duration of trial treatment, and for at least for 12 months after treatment for females and 4 months after treatment for males. Should a female patient (or male participant's sexual partner) become pregnant or should either the female patient (or male participant's partner) suspect she is pregnant while the participant's study-participation is ongoing, the treating physician should be informed immediately.

Exclusion criteria

Exclusion Criteria:

  1. If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
  2. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  3. Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).
  4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the study subject's best interest to participate, in the opinion of the treating investigator.
  5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  6. Pregnant or nursing women
  7. For women of childbearing age, a serum pregnancy test will be required within 72 hours prior to enrollment. If the serum test is positive, patient will not be allowed to enroll in the trial.
  8. Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial.
  9. Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Arm A

    Will receive FMT therapy (both as a colonoscopy / FMT procedure and as capsules taken by mouth) plus the scheduled chemotherapy and CAR-T cell therapy.

    Drug: Fecal Microbiota Transplantation · Procedure: Chemotherapy · Procedure: CAR-T Therapy

  • Experimental
    Arm B

    Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy.

    Procedure: Chemotherapy · Procedure: CAR-T Therapy

Interventions

  • DrugFecal Microbiota Transplantation

    Given by PO

  • ProcedureChemotherapy

    Given by Infusion

  • ProcedureCAR-T Therapy

    Given by Infusion

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What researchers measure

Primary outcomes

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Time frame: Through study completion; an average of 1 year.

07

Study locations

1 of 1 sites recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Neeraj Saini, MD · Contact · nsaini@mdanderson.org · 713-792-4504
    • Neeraj Saini, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Prasad R, Rehman A, Rehman L, Darbaniyan F, Blumenberg V, Schubert ML, Mor U, Zamir E, Schmidt S, Hayase T, Chang CC, McDaniel L, Flores I, Strati P, Nair R, Chihara D, Fayad LE, Ahmed S, Iyer SP, Wang M, Jain P, Nastoupil LJ, Westin J, Arora R, Turner J, Khawaja F, Wu R, Dennison JB, Menges M, Hidalgo-Vargas M, Reid K, Davila ML, Dreger P, Korell F, Schmitt A, Tanner MR, Champlin RE, Flowers CR, Shpall EJ, Hanash S, Neelapu SS, Schmitt M, Subklewe M, Francois-Fahrmann J, Stein-Thoeringer CK, Elinav E, Jain MD, Hayase E, Jenq RR, Saini NY. Antibiotic-induced loss of gut microbiome metabolic output correlates with clinical responses to CAR T-cell therapy. Blood. 2025 Feb 20;145(8):823-839. doi: 10.1182/blood.2024025366. PubMed 39441941 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 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
NCT06218602
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
Feb 19, 2024
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Neeraj Saini, MD
Contact
nsaini@mdanderson.org
(713) 792-4504
Neeraj Saini, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

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

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